SINGLE USE INFANT 280ML RESUSCITATOR W/ POP-OFF 40

GUDID 04716770236209

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, manual, single-use
Primary Device ID04716770236209
NIH Device Record Keyb278f241-49a6-4eff-af9f-628d9aba6d97
Commercial Distribution StatusIn Commercial Distribution
Brand NameSINGLE USE INFANT 280ML RESUSCITATOR W/ POP-OFF 40
Version Model NumberRE-23620
Company DUNS658023775
Company NameBESMED HEALTH BUSINESS CORP.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104716770236209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTMVentilator, Emergency, Manual (Resuscitator)

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 Date2016-05-23

On-Brand Devices [SINGLE USE INFANT 280ML RESUSCITATOR W/ POP-OFF 40]

04716770256108RE-25610
04716770246239RE-24623
04716770246222SINGLE USE INFANT 280ML RESUSCITATOR W/ POP-OFF 40CM H2O,L TYPE ADAPTER WITH MANOMETER POR
04716770246208RE-24620
04716770246109RE-24610
04716770236209RE-23620
04716770226156RE-22615

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