Identity
- Trade Name
- FilteredFlo® PACU Adult Blanket FDA UDI
- Generic Name
- External circulating-air core temperature regulation system pad, single-use FDA UDI
- Device Name
- Thermal Regulating System FDA UDI
- Model / Reference
- 243 FDA UDI
- Description
- Thermal Regulating System FDA UDI
Identifiers
- Catalog Number
- 82243 FDA UDI
- Primary DI / UDI-DI
- 10613031822434 FDA UDI
- FDA Product Code
- DWJ FDA UDI
- GMDN Term
- External circulating-air core temperature regulation system pad, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5900 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 50.0 Inch FDA UDILength — 92.0 Inch FDA UDIWeight — 0.67 Pound FDA UDI
FilteredFlo® PACU Adult Blanket by Gentherm Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Gentherm Medical, LLC
Sources (1)
- FDA UDI 698e5640-8b4d-4b2e-874a-07179259a375 38 fields · synced Jun 6, 2026