Identity
- Trade Name
- Tempo FDA UDI
- Generic Name
- Hot/cold therapy pack, single-use FDA UDI
- Device Name
- Instant Cold Compress. Single Use. Urea Formula. Nonwoven Pouch. 6"x6.25" FDA UDI
- Model / Reference
- ICE6650CC FDA UDI
- Description
- Instant Cold Compress. Single Use. Urea Formula. Nonwoven Pouch. 6"x6.25" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857425005956 FDA UDI
- FDA Product Code
- IMD FDA UDI
- GMDN Term
- Hot/cold therapy pack, single-use 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hot/cold therapy pack, single-use
Tempo by Hemasource — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hot/cold therapy pack, single-use.
- B-COOL UNIV WRAP COLD THERAPY KIT — BIRD & CRONIN, LLC · Class I
- Halyard — OWENS & MINOR DISTRIBUTION, INC. · Class I
- CareStock — MCKESSON MEDICAL-SURGICAL INC. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- Redicare — REDICARE LLC · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- ASP MEDICAL — Asp Global, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hemasource
Sources (1)
- FDA UDI 9cc3c36e-c4f0-4472-b785-2e15fa2f1b48 33 fields · synced Jun 8, 2026