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Buddy Lite With Ac, Battery Housing And Heater Unit, Australia

FDA UDI

Class II (US FDA UDI)

by Belmont Instrument Corp.

Identity

Trade Name
BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT,AUSTRALIA FDA UDI
Generic Name
Conduction blood/fluid warmer FDA UDI
Device Name
ASSY, BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, AUSTRALIA CHARGER FDA UDI
Model / Reference
905-00040 FDA UDI
Description
ASSY, BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, AUSTRALIA CHARGER FDA UDI

Identifiers

Primary DI / UDI-DI
60896128002444 FDA UDI
510(k) Number
K112639 FDA UDI
FDA Product Code
BSB FDA UDI
GMDN Term
Conduction blood/fluid warmer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9205 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

Buddy Lite With Ac, Battery Housing And Heater Unit, Australia by Belmont Instrument Corp. — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K112639 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Belmont Instrument Corp.

Sources (1)

  • FDA UDI 670667a8-5865-4865-88b8-5c28b38a9682 35 fields · synced May 30, 2026