SILICONE ADULT 1700ML RESUSCITATOR W/ POP-OFF 60CM

GUDID 04716770231709

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, pneumatic, reusable
Primary Device ID04716770231709
NIH Device Record Keyac8f46f2-c553-438d-9d6a-91ba3cdc0e49
Commercial Distribution StatusIn Commercial Distribution
Brand NameSILICONE ADULT 1700ML RESUSCITATOR W/ POP-OFF 60CM
Version Model NumberRE-23170
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
GS104716770231709 [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 ADULT 1700ML RESUSCITATOR W/ POP-OFF 60CM]

04716770231709RE-23170
04716770231303RE-23130

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