Identity
- Trade Name
- VascuTherm5 FDA UDI
- Generic Name
- Single-chamber venous compression system garment, single-use FDA UDI
- Device Name
- VascuTherm5 Therapy System FDA UDI
- Model / Reference
- 0P9PTVT500 FDA UDI
- Description
- VascuTherm5 Therapy System FDA UDI
Identifiers
- Catalog Number
- 0P9PTVT500 FDA UDI
- Primary DI / UDI-DI
- B5850P9PTVT5000 FDA UDI
- FDA Product Code
- JOW FDA UDIILO FDA UDI
- GMDN Term
- Single-chamber venous compression system garment, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5800 FDA UDI890.5720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
Yes
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Circulating-fluid localized thermal therapy system pack, single-useCirculating-fluid localized thermal/compression therapy system wrapSingle-chamber venous compression system garment, single-useCirculating-fluid localized thermal/compression therapy system control unit
VascuTherm5 by Thermotek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Circulating-fluid localized thermal/compression therapy system control unit.
- Med4 Elite — Avanos Medical, Inc. · Class II
- Med4 Elite — Avanos Medical, Inc. · Class II
- Med4Elite Accessories — Avanos Medical, Inc. · Class II
- Game Ready — Avanos Medical, Inc. · Class II
- Game Ready GRPRO 2.1 System Demo — Avanos Medical, Inc. · Class II
- Game Ready — Avanos Medical, Inc. · Class II
- Med4 Elite — Avanos Medical, Inc. · Class II
- Med4 Elite — Avanos Medical, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thermotek, Inc.
Sources (1)
- FDA UDI f87faa60-de9b-4ef1-b8c9-9d82442a9b96 35 fields · synced Jun 1, 2026