Home GUDID 06975435800058 Omay
Primary DI 06975435800058
Brand Omay
Company Omay(Guangzhou) Med Technologies Co.,Ltd
Model Omay-A
Published 2023-12-21
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe Product Codes# Code, Name table Code Name DRN Device, Counter-Pulsating, External
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DRN Device, Counter-Pulsating, External Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 06975435800058 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06975435800058 06975435800058 6975435800058
GMDN Terms# Term, Definition table Term Definition External counterpulsation system, stationary A noninvasive, stationary assembly of devices intended to assist the blood circulation of an adult patient suffering from heart disease through the electrocardiogram (ECG) synchronized inflation of pressure cuffs worn around the extremities/buttocks. It includes a patient bed with inflatable cuffs, an air pump, ECG cables, and either a control unit or software for use with a personal computer (PC); it may include a pulse oximeter probe. The cuffs are intended to inflate from the most distal to the most proximal during diastole and deflate during systole to increase preload/decrease afterload. The system is intended to be operated by a professional in a clinical setting.
Regulatory Flags# DUNS number 547000751 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06979448890020 Huawen Vamed Medical Instrument Co.,Ltd DRN 2026-04-17 06971379470067 PSK, Air-bag Type Sequential External Counter-pulsation Device Chongqing PSK-Health Sci-Tech Development Co.,Ltd. DRN 2025-04-15 06971379470074 PSK, Air-bag Type Sequential External Counter-pulsation Device Chongqing PSK-Health Sci-Tech Development Co.,Ltd. DRN 2025-04-15 00865089000316 RenewTM NCP-5 External Counterpulsation System S2 Equipment LLC DRN 2018-06-25 06971379470012 ECP PSK Chongqing PSK-Health Sci-Tech Development Co.,Ltd. DRN 2017-12-04 06971379470029 ECP PSK Chongqing PSK-Health Sci-Tech Development Co.,Ltd. DRN 2017-12-04 00868331000409 RejuvaHeart NORTH AMERICAN ECP INC. DRN 2017-10-17 08883000001640 RenewTM NCP-5 External Counterpulsation System RENEW GROUP PRIVATE LIMITED DRN 2017-03-15 00817980020740 Vasomedical™ AngioNew -V EECP® Therapy System VASOMEDICAL, INC. DRN 2016-11-29 00817980020757 Vasomedical™ AngioNew -V EECP® Therapy System VASOMEDICAL, INC. DRN 2016-11-29 00817980020764 Vasomedical™ AngioNew -VI EECP® Therapy System VASOMEDICAL, INC. DRN 2016-11-29 00817980020771 Vasomedical™ AngioNew -VI EECP® Therapy System VASOMEDICAL, INC. DRN 2016-11-29 00817980020788 Vasomedical™Lumenair™ EECP® Therapy System VASOMEDICAL, INC. DRN 2016-11-29 00817980020795 Vasomedical™Lumenair™ EECP® Therapy System VASOMEDICAL, INC. DRN 2016-11-29 00817980020801 Vasomedical™ TS-4 EECP® Therapy System VASOMEDICAL, INC. DRN 2016-11-29 00817980020818 Vasomedical™ TS-4EECP® Therapy System VASOMEDICAL, INC. DRN 2016-11-29 00817980020825 Z-Fold ECG Paper, 147 ft. (Models TS3, and TS4 and Lumenair™) VASOMEDICAL, INC. DRN 2016-11-29 00817980020832 Roll ECG Paper, 240 ft. (Model MC2) VASOMEDICAL, INC. DRN 2016-11-29 00817980020849 Nu Prep Gel, 4 oz (3 PK) VASOMEDICAL, INC. DRN 2016-11-29 00817980020856 Signa Electrode Gel, 8 oz VASOMEDICAL, INC. DRN 2016-11-29 00817980020863 Signa Electrode Gel, 2 oz VASOMEDICAL, INC. DRN 2016-11-29 00817980020870 3 Lead Integrated ECG Cable (AngioNew® V & VI) VASOMEDICAL, INC. DRN 2016-11-29 00817980020887 3 Lead Integrated ECG Cable (Models MC2, TS4 and Lumenair™) VASOMEDICAL, INC. DRN 2016-11-29 00817980020894 3 Lead Integrated ECG Cable with adapter (Model TS3) VASOMEDICAL, INC. DRN 2016-11-29 00817980020900 ECG Cable Adaptor-for use with V10-0017 (Model TS3) VASOMEDICAL, INC. DRN 2016-11-29 00817980020917 Electrodes (600 per case) VASOMEDICAL, INC. DRN 2016-11-29 00817980020924 Cuff Set, X-Small VASOMEDICAL, INC. DRN 2016-11-29 00817980020931 Cuff Set, Small VASOMEDICAL, INC. DRN 2016-11-29 00817980020948 Cuff Set, Medium VASOMEDICAL, INC. DRN 2016-11-29 00817980020955 Cuff Set, Large VASOMEDICAL, INC. DRN 2016-11-29