Identity
- Trade Name
- Game Ready FDA UDI
- Generic Name
- Circulating-fluid localized thermal/compression therapy system control unit FDA UDI
- Device Name
- EU-Battery Detachable Power Cord FDA UDI
- Model / Reference
- 303529 FDA UDI
- Description
- EU-Battery Detachable Power Cord FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812120000033 FDA UDI
- FDA Product Code
- ILO FDA UDIIRP FDA UDI
- GMDN Term
- Circulating-fluid localized thermal/compression therapy system control unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5720 FDA UDI890.5650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Circulating-fluid localized thermal/compression therapy system control unit
Game Ready by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- BREG — Breg, Inc. · Class II
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
- Avanos Medical, Inc.
Sources (1)
- FDA UDI 2de11255-551d-4049-bfc1-f3ae59680035 33 fields · synced Jun 9, 2026