buddy 2 SYSTEM

GUDID 00896128002831

BUDDY 2 SYSTEM, ENGLISH

BELMONT INSTRUMENT CORPORATION

Conduction blood/fluid warmer
Primary Device ID00896128002831
NIH Device Record Key7cf78a32-1656-44f3-b00d-2869535d1155
Commercial Distribution StatusIn Commercial Distribution
Brand Namebuddy 2 SYSTEM
Version Model Number905-00037-E
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
GS100896128002831 [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 Number4
Public Version Date2022-03-22
Device Publish Date2016-09-23

On-Brand Devices [buddy 2 SYSTEM]

20896128002828BUDDY 2 SYSTEM, FRENCH
10896128002821BUDDY 2 SYSTEM, DUTCH
00896128002855BUDDY 2 SYSTEM,GERMANY
00896128002848BUDDY 2 SYSTEM, UK
00896128002831BUDDY 2 SYSTEM, ENGLISH

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