SINGLE USE ADULT 1600ML RESUSCITATOR W/ POP-OFF 60

GUDID 04716770224459

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, manual, single-use
Primary Device ID04716770224459
NIH Device Record Keyee05cf22-57b9-4412-bdd3-ca8607770173
Commercial Distribution StatusIn Commercial Distribution
Brand NameSINGLE USE ADULT 1600ML RESUSCITATOR W/ POP-OFF 60
Version Model NumberRE-22445
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
GS104716770224459 [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 ADULT 1600ML RESUSCITATOR W/ POP-OFF 60]

04716770244433RE-24443
04716770244402RE-24440
04716770244204RE-24420
04716770224459RE-22445
04716770224251RE-22425

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