Zephyr Vascular Compression Device
The Zephyr Vascular Compression Device Model 9200-10 has two easily inflatable compression balloons, one for the radial artery and one for the ulnar artery, that are easily adjustable to…
The Zephyr Vascular Compression Device Model 9200-10 has two easily inflatable compression balloons, one for the radial artery and one for the ulnar artery, that are easily adjustable to help facilitate patent hemostasis in the radial artery. The Model 9200-10 provides the regular strap which is 9.8”/25cm long.
Who Else Makes It
Concentrated in Beijing (3), Zhejiang (2), Guangdong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 3 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Terumo Medical Products (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
Record
| Listed by | Semler Technologies, Inc., United States |
|---|---|
| FDA product code | DXC |
| Device type | Clamp, Vascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4450 |
| 510(k) | K151363 |
| Record published | 2016-09-24 |
| Record revised | 2024-10-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 50, bag of 10, casse of 50 |
| Distribution end date | 2023-06-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9100-20 | In distribution | |
| 9100-00 | Withdrawn | |
| 9200-00 | Withdrawn | |
| 9100-00 | Withdrawn | |
| 9200-10 | Withdrawn | |
| 9100-20 | Withdrawn | |
| 9200-20 | Withdrawn | |
| 9100-10 | Withdrawn | |
| 9200-20 | Withdrawn | |
| 9200-10 | Withdrawn | |
| 9200-00 | Withdrawn | |
| 9100-10 | Withdrawn | |
| 9100-20 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 831 |
| Novo Surgical | Novo Surgical, Inc. | 708 |
| Ambler Surgical | Ambler Surgical, LLC | 575 |
| Pilling | Teleflex Medical LLC | 544 |
| Avalign | Avalign Technologies, Inc. | 543 |
| Boss Instruments | Boss Instruments, Ltd. | 457 |
| V. Mueller | Steris Corporation | 432 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 342 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 331 |
| Scanlan® | Scanlan International, Inc. | 294 |
| HNM Medical | HNM Stainless, LLC. | 230 |
| Aesculap | Aesculap AG | 136 |
Showing 12 of 639. All products under Clamp, Vascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K002767 | 2000-09-27 |
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.