Identity
- Trade Name
- CARDINAL HEALTH FDA UDI
- Generic Name
- Hot/cold therapy pack, reusable FDA UDI
- Device Name
- HOT/COLD GEL PACK NONTOXIC NONIRRITATING INSULATED 1CA/24EA 4.5IN X 10.5IN REUSABLE LARGE FDA UDI
- Model / Reference
- 80304A FDA UDI
- Description
- HOT/COLD GEL PACK NONTOXIC NONIRRITATING INSULATED 1CA/24EA 4.5IN X 10.5IN REUSABLE LARGE FDA UDI
Identifiers
- Catalog Number
- 80304A FDA UDI
- Primary DI / UDI-DI
- 00630140039709 FDA UDI
- FDA Product Code
- IMD FDA UDI
- GMDN Term
- Hot/cold therapy pack, reusable 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hot/cold therapy pack, reusable
Cardinal Health by Cardinal Health 200, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hot/cold therapy pack, reusable.
- Future Generation Medical — Global International L. L. C. · Class I
- Hot Cold Pack - Universal customized Cartoon pack Jurassic & Gabby's Dollhouse — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
- HOT/COLD THERAPY SLIPPER — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
- PRONTO MED — Eurosirel Spa · Class IIa
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI f6dbfede-36f0-43fa-b04d-d1bc9282a616 34 fields · synced Jun 8, 2026