BUDDY, HEATER

GUDID 10896128002111

BUDDY HEATER UNIT

BELMONT INSTRUMENT CORPORATION

Conduction blood/fluid warmer
Primary Device ID10896128002111
NIH Device Record Key8daf5f11-e80d-4b36-ac51-e8ea91e4c155
Commercial Distribution StatusIn Commercial Distribution
Brand NameBUDDY, HEATER
Version Model Number905-00005
Company DUNS078330362
Company NameBELMONT INSTRUMENT CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110896128002111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BSBWarmer, Blood, Non-Electromagnetic Radiation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [BUDDY, HEATER]

10896128002111BUDDY HEATER UNIT
00896128002114ASSY, BUDDY HEATER UNIT

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