Identity
- Trade Name
- TR BAND FDA UDI
- Generic Name
- Tourniquet cuff, single-use FDA UDI
- Device Name
- TR BAND Radial Artery Compression Device FDA UDI
- Model / Reference
- TRB24-REG FDA UDI
- Description
- TR BAND Radial Artery Compression Device FDA UDI
Identifiers
- Catalog Number
- TRB24-REG FDA UDI
- Primary DI / UDI-DI
- 00389701012469 FDA UDI
- 510(k) Number
- K213531 FDA UDI
- FDA Product Code
- DXC FDA UDI
- GMDN Term
- Tourniquet cuff, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4450 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 24 Centimeter FDA UDI
Category: Tourniquet cuff, single-use
Tr Band by Terumo Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tourniquet cuff, single-use.
- Disposable Tourniquet Cuff — Zhejiang Longyou Lande Medical Technology Co., Ltd. · Class I
- Tourniquet Cuff — Vistar Medical Supplies Co.,Ltd. · Class I
- Sterile Disposable Contour Cuff — Delfi Medical Innovations Inc · Class I
- Tourniquet cuff — NINGBO ZHUOQIU MEDICAL EQUIPMENT CO., LTD. · Class I
- Pneumatic Tourniquet Cuff — Tiantai Typhung Medical Supplies Co., Ltd · Class I
- Cuissard garrot autoclavable conique adulte XL 12x90cm DDM — SPENGLER SAS · Class I
- TMT Rigid Holster Kit w/ Malice Clip Tactical Taylor Back Attachment — SAFEGUARD US OPERATING, LLC · Class I
- Mobile Stand for Tourniquet — VBM Medizintechnik GmbH · Class I
Cleared under the same submission
K213531 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Terumo Medical Corporation
Sources (1)
- FDA UDI ad485bfa-9c45-4a44-8b55-2af21526346a 38 fields · synced Jun 8, 2026