Tourniquet, Pneumatic
Non-Sterile Y-Fill Line, Single, Quick Connect to Quick Connect
21manufacturers in China registered for this device type
29catalogue numbers in this listing
7recalls 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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | KCY |
| Device type | Tourniquet, Pneumatic |
| Device class | Class 1 |
| Regulation | 21 CFR 878.5910 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-24 |
| Record revised | 2026-07-28 (version 8) |
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 |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10, pack of 50 |
| Sizes | Length 10 to 20 ft; length 40 to 60 in; width 4 to 6 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5920000207 | Length 20.0 ft | In distribution |
| 5920000001 | Length 40.0 in | In distribution |
| 5920000306 | In distribution | |
| 5920000205 | Length 10.0 ft | In distribution |
| 5920000202 | Length 10.0 ft | In distribution |
| 5920000101 | Width 4.0 in | In distribution |
| 5920000309 | In distribution | |
| 5920000204 | Length 10.0 ft | In distribution |
| 5920000209 | Length 10.0 ft | In distribution |
| 5920000103 | Width 4.0 in | In distribution |
| 5920000304 | In distribution | |
| 5920000002 | Length 40.0 in | In distribution |
| 5920000203 | Length 10.0 ft | In distribution |
| 5920000305 | In distribution | |
| 5920000007 | Length 60.0 in | In distribution |
| 5920000302 | In distribution | |
| 5920000006 | Length 40.0 in | In distribution |
| 5920000008 | Length 60.0 in | In distribution |
| 5920000206 | Length 10.0 ft | In distribution |
| 5920000301 | In distribution | |
| 5920000201 | Length 10.0 ft | In distribution |
| 5920000303 | In distribution | |
| 5920000208 | Length 10.0 ft | In distribution |
| 5920000004 | Length 60.0 in | In distribution |
| 5920000307 | In distribution | |
| 5920000104 | Width 6.0 in | In distribution |
| 5920000005 | Length 40.0 in | In distribution |
| 5920000003 | Length 60.0 in | In distribution |
| 5920000102 | Width 6.0 in | 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
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-11-06 | Class II | Under Investigation by firm | There is a potential for the cuff to leak air leading to a loss of vascular occlusion. | 16,380 total | 2021-11-19 |
| 2019-11-06 | Class II | Under Investigation by firm | There is a potential for the cuff to leak air leading to a loss of vascular occlusion. | 16,380 total | 2021-11-19 |
| 2013-12-06 | Class II | Component change control | The Color Cuff Sterile Disposable Tourniquet Cuffs with Quick-Connect Fitting may have an incorrect end-connector. A customer reported having received a luer connector instead of a quick connect fitting. An incorrect connector may lead to a | 5 boxes (50 units) | 2014-02-27 |
| 2011-08-25 | Not classified | Mixed-up of materials/components | Three complaints have been reported indicating that the product inside the package did not match the label description. The units had quick connectors instead of luer lock connectors as stated in the label description. | 5920-000-003 (30 bx) and 5920-000-005 (30 bx) | 2011-10-12 |
| 2010-04-13 | Not classified | Component design/selection | This recall is related to the Electri-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of the plug. Over time the fracture may lead to arcing inside o | 2011-05-16 | |
| 2010-04-13 | Not classified | Component design/selection | This recall is related to the Electi-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of the plug. Over time the fracture may lead to arcing inside of | 2011-05-16 | |
| 2010-04-13 | Not classified | Component design/selection | This recall is related to the Electri-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of the plug. Over time the fracture may lead to arcing inside o | 2011-05-16 |
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.