Zimmer® A.T.S.®

2 catalogue numbers from 60190900100, listed by Zimmer Orthopaedic Surgical Products, United States, under Tourniquet, Pneumatic. 21 manufacturers in China are registered for this product code.

Registry build 21.09.26
21manufacturers in China registered for this device type
2catalogue numbers in this listing
5recalls on this code

Who Else Makes It

Concentrated in Zhejiang (8), Guangdong (8), Shanghai (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KCY
Manufacturer City Province Registered as Device types
Flying Tooling Engineering Limited Dongguan Guangdong Contract manufacturer 9
Yuyao Guangjing Medical Instrument Co., Ltd. Ningbo Zhejiang Contract manufacturer 7
Zhejiang Longyou Landmedical Technology Co., Ltd. Longyou Zhejiang Contract manufacturer 7
Tiantai Shengtengyun Medical Supplies Co., Ltd. Tiantai County Zhejiang Contract manufacturer 3
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Ningbo Ningyuan Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 80
Ningbo Castle Medical Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 67
Guangzhou Nuoning Medical Supplies Co., Ltd. Guangzhou Guangdong Contract manufacturer 62
Saferlife Products Co., Ltd. Guangzhou Guangdong Contract manufacturer 58
Orantech Inc. Shenzhen Guangdong Contract manufacturer 40
Zhejiang Gene Science Co., Ltd. Shaoxing Zhejiang Manufacturer 31

Showing 12 of 21. All 21 manufacturers in China registered for Tourniquet, Pneumatic

Record

Regulatory record for Zimmer® A.T.S.®
Listed by Zimmer Orthopaedic Surgical Products, United States
FDA product code KCY
Device type Tourniquet, Pneumatic
Device class Class 1
Regulation 21 CFR 878.5910
Premarket notification Exempt
Record published 2022-08-16
Record revised 2025-03-20 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Zimmer® A.T.S.®
Catalogue number Size Status
60190900100 In distribution
60190900110 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medline Medline Industries, Inc. 128
Tourniquet, Pneumatic Stryker Sustainability Solutions 126
Tourniquet, Pneumatic VBM Medizintechnik Gmbh 120
Zimmer Provision 104
Tourniquet, Pneumatic Zimmer Orthopaedic Surgical Products 91
Color Cuff Stryker GmbH 87
Stryker Provision 57
Disposable Tourniquet Cuff Zhejiang Longyou Lande Medical Technology Co., Ltd. 45
Zimmer Tourniquet Renu Medical, Inc. 42
DTS-3000 Daesung Maref Co., Ltd. 42
ExpressAire Provision 40
Orantech Orantech Inc. 35

Showing 12 of 94. All products under Tourniquet, Pneumatic

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity Closed
2005-02-11 Not classified Other The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release. Total 430 cuffs 2006-04-07
2005-02-11 Not classified Other The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release. Total 1460 cuffs 2006-04-07
2004-10-27 Not classified Other The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release. 42 units (10 cuffs per unit) 2005-12-20
2004-10-27 Not classified Other The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release. Total 53100 cuffs 2005-12-20
2004-10-27 Not classified Other The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release. Total 45730 cuffs 2005-12-20

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