Identity
- Trade Name
- HOMEDICS FDA UDI
- Generic Name
- Hot/cold therapy pack, reusable FDA UDI
- Device Name
- Reusable Gel Sleeve Ankle FDA UDI
- Model / Reference
- SR-GA800J FDA UDI
- Description
- Reusable Gel Sleeve Ankle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00031262112002 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
Yes
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
Homedics by Fka Distributing Co., Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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
- Fka Distributing Co., Llc
Sources (1)
- FDA UDI ecb338ac-77ab-471d-bc27-92469c1e34a5 33 fields · synced Jun 8, 2026