TR Band
TR Band applies adjustable wrist compression after transradial catheterization to achieve hemostasis while allowing radial artery patency to be maintained. A clear plastic belt with…
TR Band applies adjustable wrist compression after transradial catheterization to achieve hemostasis while allowing radial artery patency to be maintained. A clear plastic belt with hook-and-loop fasteners carries two compression balloons.
A dedicated 20 mL inflator injects or removes air through a valved port, filling both balloons together and permitting fine pressure adjustment. A support plate helps the assembly follow wrist contours.
Listed Item
TR BAND Radial Artery Compression Device
Visibility and Supply
Clear belt and balloon materials allow observation of the access site during hemostasis. The device is individually packaged and ethylene-oxide sterilized for single use. It is placed around the wrist after the procedure and applies pressure as the introducer sheath is removed.
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 | Terumo Corp., Japan |
|---|---|
| FDA product code | DXC |
| Device type | Clamp, Vascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4450 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K213531 |
| Record published | 2022-10-07 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Avoid direct sunlight. Keep dry; Special storage condition: Do not store at extreme temperature and humidity |
| Packaging | Pack of 5, pack of 4, carton of 20, shelfbox of 5 |
| Sizes | Length 24 to 29 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TRB29-LRG | Contents: Large Band and 25 mL Inflation Syringe | In distribution |
| TRB29-LRG | Contents: Large Band and 25 mL Inflation Syringe | In distribution |
| TRB24-REG | Length 24 cm | In distribution |
| TRB24-REG | Contents: Regular Band and 25 mL Inflation Syringe | 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 |
|---|---|
| K213531 | 2021-12-20 |
| K152525 | 2015-11-10 |
| K070423 | 2007-03-28 |
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.