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Bair Hugger™

FDA UDI

Class II (US FDA UDI)

by 3m Company

Identity

Trade Name
Bair Hugger™ FDA UDI
Generic Name
External circulating-air core temperature regulation system control unit, heating/cooling FDA UDI
Device Name
3M™ Bair Hugger® Patient Warming Unit, Model 795, 120V-ENG-E, Refurbished 79500 FDA UDI
Model / Reference
79500 FDA UDI
Description
3M™ Bair Hugger® Patient Warming Unit, Model 795, 120V-ENG-E, Refurbished 79500 FDA UDI

Identifiers

Catalog Number
79500 FDA UDI
Primary DI / UDI-DI
00608223795002 FDA UDI
510(k) Number
K060865 FDA UDI
FDA Product Code
DWJ FDA UDI
GMDN Term
External circulating-air core temperature regulation system control unit, heating/cooling 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Bair Hugger™ by 3m Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K060865 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
3m Company

Sources (1)

  • FDA UDI 4b3add89-0b71-4866-959b-aa986d8eb4f7 37 fields · synced Jun 1, 2026