SILICONE ADULT 1000ML RESUSCITATOR W/ POP-OFF 60CM H2O, L TYPE ADAPTER

GUDID 04716770000176

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, pneumatic, reusable
Primary Device ID04716770000176
NIH Device Record Key0dc0dec0-3e1e-4417-b1ff-59b6f1dfa3ee
Commercial Distribution Discontinuation2020-02-05
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSILICONE ADULT 1000ML RESUSCITATOR W/ POP-OFF 60CM H2O, L TYPE ADAPTER
Version Model NumberRE-23172
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
GS104716770000176 [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 Number5
Public Version Date2020-02-05
Device Publish Date2016-05-23

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