SILICONE ADULT 1600ML RESUSCITATOR W/O POP-OFF

GUDID 04716770221151

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, pneumatic, reusable
Primary Device ID04716770221151
NIH Device Record Key956649c6-60c6-4485-bc77-87c95c9d8d0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSILICONE ADULT 1600ML RESUSCITATOR W/O POP-OFF
Version Model NumberRE-22115
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
GS104716770221151 [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/O POP-OFF ]

04716770241258RE-24125
04716770241159RE-24115
04716770221250RE-22125
04716770221151RE-22115

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