SINGLE USE NEONATE 180ML RESUSCITATOR W/RENDELL BA

GUDID 04716770280035

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, manual, single-use
Primary Device ID04716770280035
NIH Device Record Key50c097b0-ff8a-4010-8e00-b4a9fb910b24
Commercial Distribution StatusIn Commercial Distribution
Brand NameSINGLE USE NEONATE 180ML RESUSCITATOR W/RENDELL BA
Version Model NumberRE-28003
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
GS104716770280035 [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 Date2016-09-06

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