Identity
- Trade Name
- Kozee FDA UDI
- Generic Name
- Circulating-air whole-body heating system control unit FDA UDI
- Device Name
- Small Warming Suit FDA UDI
- Model / Reference
- M21301 FDA UDI
- Description
- Small Warming Suit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08973920006693 FDA UDI
- FDA Product Code
- DWJ FDA UDI
- GMDN Term
- Circulating-air whole-body heating system control unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5900 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Circulating-air whole-body heating system control unit
Kozee by Sourcemark, Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Sourcemark, Llc.
Sources (1)
- FDA UDI 57e50ea9-7433-4250-ac36-21aca0fb33ca 33 fields · synced Jun 1, 2026