SILICONE INFANT 280ML RESUSCITATOR W/ POP-OFF 40CM

GUDID 04716770253107

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, pneumatic, reusable
Primary Device ID04716770253107
NIH Device Record Key0edf6676-7084-4b47-8f43-55b1228e54e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSILICONE INFANT 280ML RESUSCITATOR W/ POP-OFF 40CM
Version Model NumberRE-25310
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
GS104716770253107 [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 INFANT 280ML RESUSCITATOR W/ POP-OFF 40CM]

04716770253107RE-25310
04716770243450RE-24345
04716770243351RE-24335
04716770233307RE-23330
04716770223452RE-22345
04716770223254RE-22325

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