A.T.S.®
Single Hose with CPC Connectors
21manufacturers in China registered for this device type
14catalogue 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.
| 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
| 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 | 2021-07-21 |
| Record revised | 2025-03-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Shelf carton of 10, ship case of 2 |
| Sizes | Length 36 in; height 28 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 60-4018-001-00 | In distribution | ||
| 60-4009-001-00 | Length 36 in | In distribution | |
| 60-2790-001-00 | In distribution | ||
| 60-4022-001-00 | In distribution | ||
| 60-4022-001-00 | In distribution | ||
| 60-4017-001-00 | In distribution | ||
| 60-4009-101-00 | In distribution | ||
| 60-4022-001-65 | Height 28.00 in | In distribution | |
| 60-1812-001-00 | Length 36 in | In distribution | |
| 60-7600-400-00 | 2 | In distribution | |
| 60-7300-105-00 | 4 | In distribution | |
| 60-1908-001-00 | In distribution | ||
| 60-2790-002-00 | In distribution | ||
| 60-7600-300-00 | 2 | In distribution |
Same 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 Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Zimmer Surgical, Inc. | UDI-DI | 2026-06-09 | Class II | Under Investigation by firm | Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily availabl | 14360 |
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.
| 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.