SINGLE USE CHILD 500ML RESUSCITATOR W/ POP-OFF 40CM H2O (ALL IN ONE-INTAKE VALV

GUDID 04716770000190

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, manual, single-use
Primary Device ID04716770000190
NIH Device Record Key8c955212-932a-4db2-81d9-bcf739035e8e
Commercial Distribution Discontinuation2020-02-05
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSINGLE USE CHILD 500ML RESUSCITATOR W/ POP-OFF 40CM H2O (ALL IN ONE-INTAKE VALV
Version Model NumberRE-24510
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
GS104716770000190 [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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