Identity
- Trade Name
- BIOS Diagnostics FDA UDI
- Generic Name
- Cold/cool therapy gel FDA UDI
- Device Name
- Cooling Gel Patches (4 Pack) FDA UDI
- Model / Reference
- CP305 FDA UDI
- Description
- Cooling Gel Patches (4 Pack) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00057475363055 FDA UDI
- FDA Product Code
- OMW FDA UDI
- GMDN Term
- Cold/cool therapy gel FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5710 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cold/cool therapy gel
BIOS Diagnostics by Thermor Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cold/cool therapy gel.
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- RTMED — Shandong Haidike Medical Products Co., Ltd. · Class I
- BeKoool — KOBAYASHI CONSUMER PRODUCTS, LLC · Class I
- BeKoool — KOBAYASHI CONSUMER PRODUCTS, LLC · Class I
- BeKoool — KOBAYASHI CONSUMER PRODUCTS, LLC · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Thermor Ltd
Sources (1)
- FDA UDI c9b255ca-74d0-49dc-995f-5e59e1a594c2 33 fields · synced May 30, 2026