Identity
- Trade Name
- Bair Hugger™ FDA UDI
- Generic Name
- External circulating-air core temperature regulation system pad, single-use FDA UDI
- Device Name
- 3M™ Bair Hugger™ Flex Warming Gown with Booties, Standard, 30 per case, 83003 FDA UDI
- Model / Reference
- 83003 FDA UDI
- Description
- 3M™ Bair Hugger™ Flex Warming Gown with Booties, Standard, 30 per case, 83003 FDA UDI
Identifiers
- Catalog Number
- 83003 FDA UDI
- Primary DI / UDI-DI
- 50707387774443 FDA UDI
- 510(k) Number
- K060865 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
- 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
Category: External circulating-air core temperature regulation system pad, single-use
Bair Hugger™ by 3m Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as External circulating-air core temperature regulation system pad, single-use.
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- Level 1 — ICU MEDICAL, INC. · Class II
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Cleared under the same submission
K060865 also covers:
- 3M™ — 3M COMPANY
- 3M™ — 3M COMPANY
- 3M™ Bair Hugger™ — 3M COMPANY
- 3M™ Bair Hugger™ — 3M COMPANY
- 3M™ Bair Hugger™ — 3M COMPANY
- 3M™ Bair Hugger™ — 3M COMPANY
- 3M™ Bair Hugger™ — 3M COMPANY
- 3M™ Bair Hugger™ — 3M COMPANY
- 3M™ Bair Hugger™ — 3M COMPANY
- 3M™ Bair Hugger™ — 3M COMPANY
- Bair Hugger™ — 3M COMPANY
- Bair Hugger™ — 3M COMPANY
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA UDI c29a9ae7-ceab-4dd0-8b82-6a9dea6d3068 36 fields · synced May 30, 2026