Identity
- Trade Name
- Cold Therapy Temp-Pads® FDA UDI
- Generic Name
- Circulating-fluid localized thermal therapy system pack, single-use FDA UDI
- Device Name
- Water Circulating Hot or Cold Pack FDA UDI
- Model / Reference
- 814-USS FDA UDI
- Description
- Water Circulating Hot or Cold Pack FDA UDI
Identifiers
- Catalog Number
- 50634 FDA UDI
- Primary DI / UDI-DI
- 20613031506348 FDA UDI
- FDA Product Code
- ILO FDA UDI
- GMDN Term
- Circulating-fluid localized thermal therapy system pack, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Width — 8.0 Inch FDA UDILength — 14.0 Inch FDA UDIWeight — 0.36 Pound FDA UDI
Category: Circulating-fluid localized thermal therapy system pack, single-use
Cold Therapy Temp-Pads are compact, portable water circulating hot or cold packs designed for localized thermal therapy to alleviate musculoskeletal pain and discomfort. These single-use devices provide targeted heat and/or cold therapy, making them suitable for both professional and home settings.
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Also classified as Circulating-fluid localized thermal therapy system pack, single-use.
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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 |
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Manufacturer
- Manufacturer
- Gentherm Medical, LLC
Sources (1)
- FDA UDI 3cd95261-845c-4dc5-8108-f336d2c6b497 37 fields · synced Jul 20, 2026