Identity
- Trade Name
- BIOS Living FDA UDI
- Generic Name
- Hot/cold therapy pack, reusable FDA UDI
- Device Name
- Gel Bead Knee Wrap FDA UDI
- Model / Reference
- LH193 FDA UDI
- Description
- Gel Bead Knee Wrap FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00057475281939 FDA UDI
- FDA Product Code
- IME FDA UDI
- GMDN Term
- Hot/cold therapy pack, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5700 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
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: Hot/cold therapy pack, reusable
BIOS Living by Thermor Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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- HOT/COLD THERAPEUTIC PACK FOR KNEE — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
- hot cold pack — Anhui Kamt Ice Pack Co.,Ltd. · Class I
- HotCold Pack reusable — Bevaplast B.V. · Class I
- reusable cold hot gel pack for Ankle — Wuhan Pakcare Bio‐technology Co.,Ltd. · 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 f5e22d37-9a62-4071-a1a3-c961e8be0deb 33 fields · synced Jun 8, 2026