Identity
- Trade Name
- Whitehall Thermalators FDA UDI
- Generic Name
- Cold therapy pack chilling unit FDA UDI
- Device Name
- THERMALATOR, 12PK MOBILE, AMBER FDA UDI
- Model / Reference
- T-12-M_AMBER FDA UDI
- Description
- THERMALATOR, 12PK MOBILE, AMBER FDA UDI
Identifiers
- Catalog Number
- T12MAMBER FDA UDI
- Primary DI / UDI-DI
- 00645724003946 FDA UDI
- FDA Product Code
- IRQ FDA UDI
- GMDN Term
- Cold therapy pack chilling unit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5950 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hot therapy pack heating unitCold therapy pack chilling unit
Whitehall Thermalators by Whitehall Manufacturing Co — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Whitehall Thermalators — Whitehall Manufacturing Co · Class I
- Whitehall Thermalators — Whitehall Manufacturing Co · Class I
- Whitehall Thermalators — Whitehall Manufacturing Co · 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
- Whitehall Manufacturing Co
Sources (1)
- FDA UDI 5af796b9-4687-48fb-9d1c-063020925ace 35 fields · synced Jun 1, 2026