SINGLE USE ADULT 1600ML RESUSCITATOR W/O POP-OFF ,

GUDID 04716770224350

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, manual, single-use
Primary Device ID04716770224350
NIH Device Record Key19847cf1-ca52-45a5-8849-04853d055365
Commercial Distribution StatusIn Commercial Distribution
Brand NameSINGLE USE ADULT 1600ML RESUSCITATOR W/O POP-OFF ,
Version Model NumberRE-22435
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
GS104716770224350 [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

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