SILICONE ADULT 1600ML RESUSCITATOR W/ POP-OFF 60C

GUDID 04716770221359

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, pneumatic, reusable
Primary Device ID04716770221359
NIH Device Record Key976e2ee2-3359-4a9b-a1e2-92fc9d7f7ca0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSILICONE ADULT 1600ML RESUSCITATOR W/ POP-OFF 60C
Version Model NumberRE-22135
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
GS104716770221359 [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 1600ML RESUSCITATOR W/ POP-OFF 60C]

04716770241852RE-24185
04716770241357RE-24135
04716770221458RE-22145
04716770221359RE-22135

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