Z-Brand™

3 PER Pouch, 400 Pouches PER Case, 1200/CASE

Registry build 21.09.26
33manufacturers in China registered for this device type
48catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (12), Jiangsu (6), Zhejiang (6). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DRX
Manufacturer City Province Registered as Device types
China Qingdao Bright Medical Manufacturing Co., Ltd. Qingdao Shandong Contract manufacturer 8
Linxens Healthcare (Tianjin) Co., Ltd. Jinnan District Tianjin Contract manufacturer 7
Dongguan Ruibaolian Medical Science & Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 4
Shanghai Yuechen Medical Supply Co..ltd. Shanghai Shanghai Contract manufacturer 1
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105
Ningbo Greetmed Medical Instruments Co., Ltd. Ningbo Zhejiang Specification developer 75
Shanghai NEO-Medical Import & Export Co., Ltd. Shanghai Shanghai Exporter 59
Ningbo Chibanda IMP &EXP Co., Ltd. Ningbo Zhejiang Manufacturer 59

Showing 12 of 33. All 33 manufacturers in China registered for Electrode, Electrocardiograph

Record

Regulatory record for Z-Brand™
Listed by Graphic Controls Acquisition Corporation
FDA product code DRX
Device type Electrode, Electrocardiograph
Device class Class 2
Regulation 21 CFR 870.2360
Premarket notification Exempt
Record published 2017-04-07
Record revised 2019-11-19 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Storage Storage environment temperature 50 to 90 °F; Storage environment temperature 10 to 32 °C
Packaging Pack of 1000, pack of 1200, pack of 50
Distribution end date 2020-11-30

Catalogue Numbers

Catalogue numbers for Z-Brand™
Catalogue number Size Per pack Status
Z05MC-3 3 In distribution
Z05-5 5 In distribution
Z05MTRT-5 5 In distribution
Z35-5 5 In distribution
Z05SGRT-30 30 In distribution
Z35RT-3 3 In distribution
Z05SG-50 50 In distribution
Z05MT-50 50 In distribution
Z05MCRT-50 50 In distribution
Z05SG-30 30 In distribution
Z05-50 50 In distribution
Z05MTRT-50 50 In distribution
Z05MT-5 5 In distribution
Z05MC-5 5 In distribution
Z35RT-5 5 In distribution
Z35-3 3 In distribution
Z35RT-50 50 In distribution
Z05MC-50 50 In distribution
Z05MT-3 3 In distribution
Z05SG-5 5 In distribution
Z35-50 50 In distribution
Z05SG-3 3 In distribution
Z05SGRT-50 50 In distribution
Z05MT-3 USA 400 Withdrawn
Z05MC-50 USA 20 Withdrawn
Z05SGRT-5NB USA 200 Withdrawn
Z05-5 USA 200 Withdrawn
Z05SGRT-3NB USA 400 Withdrawn
Z35-5 USA 200 Withdrawn
Z35RT-3 USA 400 Withdrawn
Z35-50 USA 200 Withdrawn
Z05SGRT-50 USA 20 Withdrawn
Z35RT-5 USA 200 Withdrawn
Z05MCRT-50 USA 20 Withdrawn
Z05-50 USA 20 Withdrawn
Z05SG-3 USA 400 Withdrawn
Z05SG-50 USA 20 Withdrawn
Z35RT-50 USA 20 Withdrawn
Z05SGRT-30 USA 40 Withdrawn
Z05SG-5 USA 200 Withdrawn
Z35-3 USA 400 Withdrawn
Z05MTRT-50 USA 20 Withdrawn
Z05MTRT-5 USA 200 Withdrawn
Z05MC-3 USA 400 Withdrawn
Z05MT-5 USA 200 Withdrawn
Z05MC-5 USA 400 Withdrawn
Z05SG-30 USA 40 Withdrawn
Z05MT-50 USA 20 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
APK APK Technology Co., Ltd. 113
Electrode, Electrocardiograph Fiab SPA 109
Swaromed Tyrolmed GmbH 93
MediMax Tech Medimax Tech Inc. 91
Kendall Cardinal Health 91
Medline Medline Industries, Inc. 78
AMC LifeSync Corporation 74
Kendall Cardinal Health 200, LLC 73
Ambu WhiteSensor Medico Electrodes International Ltd 51
S&W Leonhard Lang Gmbh 47
Vermed Graphic Controls Acquisition Corporation 45
Red Dot™ 3M Company 44

Showing 12 of 337. All products under Electrode, Electrocardiograph

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer