PH Band
The PH Band applies compression at the wrist to assist bleeding control after a transradial procedure. It is used at the radial artery access site. The band works with an inflatable…
The PH Band applies compression at the wrist to assist bleeding control after a transradial procedure. It is used at the radial artery access site. The band works with an inflatable compression bladder and includes a window through which the access site can be observed.
A secondary strap holds a compatible flat Doppler ultrasound probe just beyond the access site. The probe allows the physician to assess forward blood flow beyond the compressed area while adjusting pressure. This combines local compression with observation of arterial patency.
Device Components
The single use prescription device includes a wrist compression band, a 30 millilitre syringe and two finger cots. It is designed to be used with the recommended Doppler equipment.
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 | Medical Ingenuities, United States |
|---|---|
| FDA product code | DXC |
| Device type | Clamp, Vascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4450 |
| 510(k) | K201695 |
| Record published | 2021-04-22 |
| Record revised | 2023-02-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 41111-01 | In distribution |
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 |
|---|---|
| K201695 | 2020-10-30 |
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.