SILICONE CHILD 550ML RESUSCITATOR W/ POP-OFF 40CM

GUDID 04716770232201

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, pneumatic, reusable
Primary Device ID04716770232201
NIH Device Record Key2abbb738-61d0-45b4-92b9-02f59964f858
Commercial Distribution StatusIn Commercial Distribution
Brand NameSILICONE CHILD 550ML RESUSCITATOR W/ POP-OFF 40CM
Version Model NumberRE-23220
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 Usefalse
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
GS104716770232201 [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 [ SILICONE CHILD 550ML RESUSCITATOR W/ POP-OFF 40CM]

04716770232300RE-23230
04716770232201RE-23220
04716770232102RE-23210

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