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Gmdn code list pdf

  • Gmdn code list pdf. Aug 21, 2023 · Coming Soon: NLM will update AccessGUDID to include more Global Medical Device Nomenclature (GMDN) information . 2 Table B: List of dangerous goods in alphabetical order See Volume II 3. A, Australia, Canada and other countries are expected to adapt GMDN right away. Free Download: Full GM OBD2 Trouble Codes List and Meaning PDF This list applies to GM’s cars, including Chevy, Cadillac, Buick, and GMC. The GMDN Agency is responsible for creating and maintaining the GMDN Database, we are a UK charity and a non-profit organisation. 2. We also found that the GMDN Agency will obsolete or change a GMDN code so it isn't the best fit anymore but the TGA will still have it. • Japan adopted GMDN: translated the terms & definitions • Australian Regulation: GMDN in its requirements. See examples of GMDN codes and how they are related to UDI, regulation and hospital management. Feb 9, 2023 · The Global Medical Device Nomenclature (GMDN) provides a generic system to identify medical device products used to diagnose, monitor, treat and prevent disease or injury. GMDN codes are alphanumeric identifiers used to classify medical devices and are essential for regulatory compliance and communication across various stakeholders. txt) or view presentation slides online. Terms including the copyright, title, language, date, number of terms (28404) and various term codes. NLM will update AccessGUDID to include more Global Medical Device Nomenclature (GMDN) information - Term Codes, Code Status (Active or Obsolete), and a GMDN Implantable flag (True or False). Entering appropriate words into the Global Medical Device Nomenclature GMDN® Code/Term text box will give you a list of GMDN® Terms to choose from. The GMDN code that you choose must accurately reflect your own device. ec. pdf), Text File (. The device is typically Apr 7, 2021 · GMDN nomenclature is not free for all stakeholders. Naming and grouping –The role of GMDN GMDN Code: 35195 GMDN Term Name: Electrocardiographic monitor GMDN Term Definition: A mains electricity (AC-powered) bedside device designed to continuously detect, measure, and display a patient's electrocardiogram (ECG) through leads and sensors attached to the patient; it also typically displays heart The GMDN Agency is a registered UK charity (1154418) and non-profit organisation responsible for the ongoing maintenance of the GMDN Database. The EMDN can be accessed and downloaded in pdf and excel format at webgate. Aug 23, 2021 · Each GMDN Term has a 5-digit numeric GMDN Code and is cross-referenced to a precisely defined Term Name and Definition, as seen in this example: GMDN Term Name: ‘Scalpel, single-use’ GMDN Code: 47569 GMDN Definition: ‘A sterile, hand-held, manual surgical instrument constructed as a one- EMDN code search by operators currently using GMDN. Mar 19, 2024 · SIMILAR PDF FILES. 1 and can be accessed via the GUDID Web Interface by Coordinator and Labeler Data Entry (LDE) Users of GUDID. 3 with Biomedical engineers. GMDN Code: 47569 GMDN Code: 35195 GMDN Term Name: Electrocardiographic monitor GMDN Term Definition: A mains electricity (AC-powered) bedside device designed to continuously detect, measure, and display a patient's electrocardiogram (ECG) through leads and sensors attached to the patient; it also typically displays heart rate. (2500 types of devices) •MS info session 5th March. com Learn about the international standard for naming medical devices, its structure, usage and benefits. Initially started by the European Standards Organisations (CEN) and later supported by the Global Harmonisation Task Force (now the International Medical Device Regulators Forum – IMDRF) to help accelerate the harmonisation of medical device regulation globally. You may also find that the GMDN code on the TGA website is different to that on the GMDN Agency. The GMDN Agency is responsible for the Global Medical Device Nomenclature (GMDN) used to name and group medical devices. The GMDN Agency is a registered UK charity and a non-profit organisation responsible for the ongoing maintenance of the GMDN database. CODE UMDNS TERM English 10534 Cabinets, Instrument Cabinets, Medicine Cabinets, Narcotic Control 10538 Cabinets, Treatment, Ultraviolet 10540 Cabinets, Warming Cabinets, Pass Box, X-ray 10542 Straps, Cable 10546 Calipers Calipers, Skinfold, Manual 10548 Caloric Irrigation Units 10549 Cameras Cameras, Fundus Cameras, Identification 10555 Cameras Jul 8, 2024 · EMDN- GMDN •Some MS support use of GMDN •WHA76 2024 •Agreement WHO with GMDN towards open policy access. Global Medical Device Nomenclature International Utilizataion • GMDN used 70 experts from 16 countries; available for development and maintenance. Other membership types have more GMDN Code Credits, you can view our membership types at this link. It lists many diagnostic test terms with their corresponding GMDN and EDMA codes. If you run out of GMDN Code Credits, please contact us. 8 Sterilization GMDN Kodu Kategori Kategori Adı (Tr) 10035 3 Diş Cihazları Yapışkan, aerosol, genel amaçlı 10082 3 Diş Cihazları Karıştırıcı, dental, amalgam 10200 3 Diş Cihazları Eklemleyici, kalıp 10201 3 Diş Cihazları Eklemleyici, dental 10455 3 Diş Cihazları Kemik kesici 10532 3 Diş Cihazları Dolap, dental Code-Search; His­to­ry and out­look; Pro­pos­al pro­ce­dure; Tab­u­lar list; Ver­sions and for­mats; ICD-11; ICD-10-WHO. GMDN codes are used to assist in the: Gmdn Edma Codes - Free download as PDF File (. 7 - Standardization of medical devices On the 1st of November 2001 the Global Medical Device Nomenclature (GMDN) was published as a CEN Report CR 14230 and as ISO. This will use one or more Code credits. Terms can be a) A list of all medical devices or IVDs imported into South Africa by product classification with the Global Medical Device Nomenclature Code (GMDN) and in the format as provided in the Licence Application for Medical Device Manufacture or Licence Ap plication for Medical Device Import and Distribution. ecri. G & M Code 1. Core medical equipment - Information Health problem addressed Blood grouping systems perform basic blood processing tests 13 meetings with the nomenclature agencies (EMDN, GMDN, UNDNS, UNSPSC). Core medical equipment - Information Health problem addressed Blood grouping systems perform basic blood processing tests Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the Global Medical Device Nomenclature International Utilizataion • GMDN used 70 experts from 16 countries; available for development and maintenance. 2. GMDN Manufacturers Code of Good Practice GMDN Manufacturers Code of Good Practice –09/06/2023. One-to-one. org | 11. e. In 1991 the first international workshop on medical device nomenclatures was held to create the GMDN. Apr 2, 2019 · On 1st of April, the GMDN Agency responsible for the Global Medical Device Nomenclature (GMDN) announced to allow users to freely obtain GMDN Terms and Codes and to get free help on their Term selection. Implementation of GMDN If the Term is already in My Terms, the GMDN Code will appear.   This is a Step-by-Step Guide for searching for GMDN Codes using the GMDN website. The GMDN Agency is a wholly UK based organisation with no subsidiaries, franchises or licenced entities outside of the UK. Click on a Term name to make GMDN - Global Medical Devices Nomenclature GMP - Good Manufacturing Practices HAS - Health Sciences Authority IFU - Instructions for Use IMDRF - International Medical Devices Regulators Forum ISO - International Organization for Standardization AR - Authorized Representative Nov 30, 2021 · The Global Medical Device Nomenclature (GMDN) and European Medical Device Nomenclature (EMDN) are two alternative approaches for naming and grouping medical devices, including implantable devices, medical equipment, consumables, and in-vitro diagnostic (IVD) devices. See: Adhesive Strips [10026] One-to-Many GMDN Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. U. Within all regulations concerned with medical devices there are a number of obligations placed upon the manufacturer. GMDN_-_Sep 2020 - Free ebook download as Excel Spreadsheet (. Band Aids. Search the on-line 5 catheters, guidewires, introducers, filters and related tools shall fall under MDN 1203 (instead of MDN 1201 or MDN 1202). Schemes List ; APCOB Notification 2023 ; ARC Branch List ; ARIIA Ranking List 2021 ; Assam Tractor Distribution Scheme Form under Add devices using GMDN® 1. Jun 18, 2023 · If you work in the medical device industry, you may be familiar with the Global Medical Device Nomenclature (GMDN) system. Regulatory networks: AMDF, GHWP, IMDRF; besides regulators in the following regions: PAHO, EURO and SEARO. Annual p aid membership fees are our primary source of income. 1 was in November 2002. Our available membership types are listed below. In Mach4 this is a carriage return Feed rate Velocity, set by F, at which an axis will move. 1 Table A: List of danger ous goods in numerical order See Volume II 3. The GMDN Search uses a ‘browser like’ search algorithm to find GMDN Terms using key words. Learn about GMDN, the international standard for naming medical devices, and how it relates to UDI. If the database does not charge. To ensure continuing permanency of the GMDN, revenues are generated through the licensing and sale of GMDN Agency products, particularly the GMDN codes. Moreover, we divide it into four parts: Powertrain, Network, Body, and Chassis, which helps you quickly find the codes you need for engine, network, body control, and chassis issues. 2 MDS codes MDS codes are horizontal codes that are applicable to devices with specific characteristics. “M” stands for Machine (or Miscellaneous), and the M-Codes are responsible for Machine commands that cause particular operations of the equipment. The device is The GMDN is an international nomenclature system used by regional or national regulatory bodies to consistently describe medical devices 1. Jun 3, 2021 · For many years, Global Medical Device Nomenclature (GMDN) The list of CND codes is available in excel and PDF and is available for download. UMDNS Components: Terms. •Vision PDF Printer Version (269 KB) Document issued on: April 11, 2013. It includes codes and descriptions for portable bathing baths, bathing stretchers, basic walkers that are foldable or non-foldable, assistive pushchairs, stand-up beds, commodes, wheelchairs, assistive ergonomic chairs, and LIST OF DANGEROUS GOODS 3. Dec 13, 2021 · ECRI Confidential ©2020 ECRI | www. •WHO open webinar with EMDN and GMDN 8TH July 2025 •Report to EB156. GMDN Code: 47569 GMDN Term Name: Scalpel, single-use GMDN Definition: A sterile, hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. New terms are issued frequently following requests from Users who are developing new … GMDN Code Read A review of the high number of types of medical devices (e. August 14, 2023 - The AccessGUDID Database has been updated to include the field for Global Medical Device Nomenclature (GMDN) Code along with the status of the GMDN Code, Active or Obsolete. Jan 27, 2022 · GMDN FOCUS – Summer 2024 August 14, 2024; South African founded company Discovery showcase how using GMDN benefits their work July 29, 2024; GMDN Agency and partners receive Innovate UK funding to research post-market medical device intelligence July 22, 2024; New Software Developer joins GMDN Agency to improve digital offering July 17, 2024 (*) Included in the main list List of priority medical devices for the first level of care - Main List (OPS, July 2019) CATEGORY MEDICAL DEVICE UMDNS GMDN RISK CLINICAL GUIDELINE Accessories & consumables Cuffs, Blood Pressure (adult/pediatric) 11-073 medium Guidelines for primary health care in low-resource settings GMDN codes and device names are reproduced with permission from the GMDN Agency. The first public release on CD-ROM as GMDN version 2002. These FDA PT codes can also This guideline is intended to provide recommendations to interested persons wishing to submit applications for the licensing of manufacturers, distributors and wholesalers, and registration of medical devices and IVDs. While accessing GMDN codes often requires a paid subscription, there are a few free resources available that Dec 13, 2021 · using GMDN Country Regulator Start Australia & NZ TGA / Medsafe 2003 United States US FDA 2013 South Africa SAHPRA 2017 Eurasian Economic Area Roszdravnadzor, et al. The webcast discussion by Member States is available for everyone. • GMDN adopted for use by EEA – i. 7 Biocompatibility BD Medical products comply with the requirements of the standard for biocompatibility of medical devices, ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing. The GMDN Agency is a registered UK charity (1154418) and non-profit organisation responsible for the ongoing maintenance of the GMDN Database. there are over 22 000 Global Medical Device Nomenclature [GMDN] term names9 / types of medical devices recognised in the GMDN data set) indicates a long process to be conducted over many years. May 11, 2024 · MasterCard, Visa (EUR, GBP, USD), Amex (USD), JCB, Maestro (GBP). 4 . 3. These files are updated every Sunday. characteristics”, and you can search according to “generic name, GMDN name, GMDN code, GMDN category, UMDNS name, UMDNS code, alternative names and others” of What is the GMDN? Global Medical Device Nomenclature (GMDN) The international standard (ISO 15225) for naming Medical Devices Used by 65 national Medical Device Regulators - Backed by IMDRF Over 4000 Manufacturers worldwide Translated into 25 languages 22,000 Preferred Terms with Definitions Controlled distribution and updating International These allow you to reveal the appropriate GMDN Term Codes for your devices (One Code per Code Credit). The member can then use a GMDN Code Credit to reveal the related GMDN Code (this is a 5-digit number). addition of GMDN codes to the database creates enhanced search and retrieval. See full list on casusconsulting. The FDA PT Codes are assigned to each GMDN term, used in place of a GMDN Code. Jul 8, 2024 · European Commission, GMDN (Global Medical Device Nomenclature) managed by the GMDN Agency, UMDNS (Universal Medical Device Nomenclature System) developed by the Emergency Care Research Institute (ECRI), and UNSPSC (United Nations Standard Products and Services Code) administered by GS1 US for the UN Development Programme. 3 with medical devices industry (GMTA, DITTA) 5 with UN agencies and NGOs. g. eu/dyna2/emdn and the European Commission’s website page for MDCG documents. (*) Included in the main list List of priority medical devices for the first level of care - Main List (OPS, July 2019) CATEGORY MEDICAL DEVICE UMDNS GMDN RISK CLINICAL GUIDELINE Accessories & consumables Cuffs, Blood Pressure (adult/pediatric) 11-073 medium Guidelines for primary health care in low-resource settings Contains Nonbinding Recommendations. Manufacturers should be referring to the GMDN agency database when selecting the appropriate GMDN codes for their Device. capabilities for all AccessGUDID users, including patients, care givers, health care providers, hospitals, and industry. Required at the end of every block of G Code. Email GMDN Global Medical Device NomenclatureGMDN (Global Medical Device Nomenclature) is composed of five digits, called GMDN code,term name (General name of the device); anddefinitionGMDN is being used in E. •2023 WHA76 2024 •Agreement WHO with GMDN towards open policy access. 47th GST Council Meeting Notification ; 53rd GST Council Meeting Press Release ; 80C Deduction List ; ALL Country Currency Name List ; All Country Names List with Capital ; AP YSR Navaratnalu Govt. It is used widely across the NHS. This document provides a correlation table between terms in the Global Medical Device Nomenclature (GMDN) and codes in the European Diagnostic Manufacturers Association (EDMA) nomenclature. xlsx), PDF File (. The correspondence between the nomenclatures is intended to be visible to operators and incorporated in the future database in the form of a searching tool. To overview The FDA supports the free Global Medical Device Nomenclature system, under development since the 1990s, that is now being used by 70 national medical device regulators from across all WHO regions. GMDN codes and device names are reproduced with permission from the GMDN Agency. txt) or read book online for free. These GMDN Term Codes will be added to your account, and you’ll receive updates regarding any future changes to these GMDN Term Codes. Apr 20, 2011 · In Australia, medical devces must be listed and have an ARTG number. These listings are done by GMDN code and class. Global Unique Device Identification Database (GUDID) Guidance for Industry and Food and Drug Administration Staff WHO list of priority medical devices for cancer management Negatoscopio 14-498 bajo WHO list of priority medical devices for cancer management Oftalmoscopio 12-815 CT1184 medio WHO list of priority medical devices for cancer management Medical Devices: managing the missmatch According to criteria and requirements set out by the European Commission and EU regulators in the Medical Device Coordination Group (MDCG) and based on orientations provided by the MDCG, the EMDN was founded following a European Commission notice indicating the utilisation of the Italian Ministry’s Classificazione Nazionale Dispositivi medici (CND) as the basis for the future EMDN. The structure, hierarchy and relationships are not freely available for consultation and download, so the public cannot take advantage of the GMDN hierarchy for analysis purposes. The manufacturer is responsible for applying the appropriate GMDN code to an IVD or a group of IVDs, as manufacturers have declared the intended purpose and are best placed to determine the correct GMDN code. Logon to the GMDN Database using your Username and Password. The new free Basic membership will allow users access to the GMDN data, while the existing membership charges will remain […] The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892. 3 Table C: List of dangerous goods accepted for carriage in tank vessels in numerical order Explanations concerning Table C: list are candidates for eventual inclusion in the List of Substances Subject to Authorization (Annex XIV of REACH). 18 members plus 10 Eastern European countries. They enable labelers to assign a GMDN term to their GUDID submission until a GMDN Code can be obtained from the GMDN Mar 27, 2008 · Brief Summary: The 12 categories in the GMDN (Global Medical Device Nomenclature) Code table are: Code Term 01 Active implantable devices 02 Anaesthetic and respiratory devices 03 Dental devices 04 Electro-mechanical devices 05 Hospital hardware 06 In vitro diagnostic devices 07 Non-active implantable devices 08 Ophthalmic and optical devices 09 Reusable instruments 10 Single use devices 11 Sep 6, 2023 · Example. Select the appropriate device type for the medical device to be registered. 6. It provides a generic or common name for devices. ISO 15225. Test Steps for Implantable Device List, 2015 Edition Health IT Certification Criteria Keywords: Health IT, ONC, EHR, Certification Criteria, CDS, Implantable Device List, 2015 Edition Health IT Certification Criteria Created Date: 12/13/2017 9:18:24 AM Adoption of GMDN 3 digits were added after GMDN 5 digits code when GMDN was translated into JMDN 1’s digit show GHTF classification when divided 10’s digit show variation (when original GMDN was too broad and separated into JMDN) 100’s digit show other division for regulatory purpose (containing biological ingredients or drug substances) EMDN code search by operators currently using GMDN. xls / . 11/1/21, 2:19 PM Global Medical Device Nomenclature (GMDN) Terms | Therapeutic Goods Administration (TGA) rationale for selecting the GMDN Term. S. Therefore, and in cooperation with GMDN, the mapping exercise is currently ongoing. The document contains information from the 2020 GMDN Agency Ltd. Anyone can register for free as a member on the GMDN website to access and use any GMDN Term Names, Definitions and GMDN Codes as well as view proposed new changes to Terms, provide comments, and ask questions. This is a Step-by-Step Guide for searching for GMDN Codes using the GMDN website. Terms can be The GMDN term GMDN Code: 35195 GMDN Term Name: Electrocardiographic monitor GMDN Term Definition: A mains electricity (AC-powered) bedside device designed to continuously detect, measure, and display a patient's electrocardiogram (ECG) through leads and sensors attached to the patient; it also typically displays heart rate. Apr 24, 2014 · Find FDA PT Code allows an LDE to search for a GMDN Preferred Term of GMDN Definition, and retrieve the FDA-assigned Preferred Term Code. Please select: WHA76 - Committee A, twelfth session, on 27/05/2023 - 09:15-11:30 that includes Member States interventions for 13. The Find FDA PT Code module is enabled in GUDID Release 1. All registered GMDN members can access the GMDN Database which currently has almost 25,000 GMDN Term Names which group your medical devices. , U. We provide all basic member accounts with 25 GMDN Code Credits when you join. The 12 categories in the GMDN (Global Medical Device Nomenclature) Code table are: Code Term 01 Active implantable devices 02 Anaesthetic and respiratory devices 03 Dental devices All medical devices sold in the US need a GMDN code European Commission uses the GMDN for their EUDAMED (market surveillance database) European UDI to become a reality soon Widely supported by device Trade Associations (Advamed, MedTech Europe, GMTA, DITTA, etc) The WHO use GMDN in their field guide for developing countries May 11, 2024 · Provide your account credentials. Guidance The GMDN (Global Medical Device Nomenclature) Code is the world-wide recognised system for naming/identification of a medical device. europa. It is managed and maintained by a not-for-profit company, the GMDN Agency, which reports to a Board of Trustees on which medical device regulators and industry are represented. HS Nomenclature 2022 edition This section contains the text of the Nomenclature established under the International Convention on the Harmonized Commodity Description and Coding System, effective from 1 January 2022. To overview: ICD-10-WHO; Al­pha­bet­i­cal in­dex; Ap­pli­ca­tion; Caus­es of death statis­tics; Code-Search; His­to­ry and out­look; In­struc­tion man­u­al; Tab­u­lar list; ICD-O-3. 1 Glossary Block A single line of G Code Canned Cycle Complex cycle defined by a single block of code Dwell Program pause with a duration defined by “P” in seconds EOB End of block. For questions about this document regarding CDRH or CBER-regulated A code which identifies a healthcare asset in the Universal Medical Device Nomenclature System™ (UMDNS) which is a standard international nomenclature and computer coding system for medical devices. TS 20225. Click on Search on the Terms dropdown menu. There are over 100 test terms listed that currently have no equivalent GMDN term assigned. 1. For Class 4 IVDs, the manufacturer must specify the relevant GMDN preferred term code, which is the unique 5-digit Members can see all 24,000+ GMDN Terms in the database. 2018 Canada Health Canada 2018 Saudi Arabia SFDA 2019 United Kingdom MHRA 2020 Thailand FDA Thailand 2021 Not exclusive list M Codes “G” stands for Geometry; hence, the G-Code commands are responsible for the movements of the machine that create the geometry of the part. The Global Unique Device Identification Database (GUDID) is a database administered by the Food and Drug Administration (FDA) that serves as a If the Term is already in My Terms, the GMDN Code will appear. It can hence be utilised by a non-exhaustive list of stake - holders such as manufacturers, patients, research organisations, practitioners, hospitals, pharmacies etc. A list of GMDN Terms in My Shortlist will be displayed to review. Non-paying users can only search and access individual codes on the GMDN website. The addition of GMDN codes to the database creates enhanced search and retrieval capabilities for all AccessGUDID users, including patients, care givers, health care providers, hospitals, and industry. The table provides a way to cross reference diagnostic In May 2023, a decision referring to medical devices codes, terms, and definitions was taken: WHA75(25). This The document provides GMDN (Global Medical Device Nomenclature) codes, descriptions, and associated medical devices for various bathing, mobility, and standing devices. 6 %âãÏÓ 1622 0 obj > endobj 1629 0 obj >/Filter/FlateDecode/ID[19D322EE288FF5489E95EA5B66011F85>]/Index[1622 12]/Info 1621 0 R/Length 53/Prev 1534555/Root Anyone can register for free as a member on the GMDN website to access and use any GMDN Term Name, Definition and Code. Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. Find out how to search, request, modify and obsolete GMDN terms, and access the FDA GUDID database. The draft of this document was issued on January 3, 2012. •Addition of EMDN terms and codes, and GMDN terms, codes and definitions in WHO platforms. Nov 23, 2021 · The CDRH database links medical devices to the appropriate regulation that contains a product definition and is published in Title 21, Code of Federal Regulations. Entering more words into the box will reduce the list. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans. Note: The GMDN Code won’t be revealed until the member opens My Shortlist and confirms the purchase by clicking on the individual Get button or Get All button. GMDN Code: 47569 Aug 16, 2023 · The Global Medical Device Nomenclature (GMDN) Code has been added to the AccessGUDID Database of medical device identification information. The document is a table that correlates terms between the Global Medical Device Nomenclature (GMDN) and the European Diagnostic Manufacturers Association (EDMA) codes. Log in Provide your account credentials. %PDF-1. Mar 22, 2024 · EMDN- GMDN-UMDNS- UNSPSC •2022 WHA75 Decision WHA75(25) •Upon request Of some MS, use of EMDN codes and terms in WHO publications and electronic platforms 2023 •EB152 •Cross reference EMDN- GMDN •Work with GMDN upon request of some Member States during WHA and EB. The GMDN has approximately 15,000 members with more than 9 out of 10 on our free Basic Membership. zhfm piv afb xpkpi hil ckynlay peyvto haort bwvuqr uqrnb