SINGLE USE CHILD 500ML RESUSCITATOR W/ POP-OFF 40

GUDID 04716770245225

SINGLE USE CHILD 500ML RESUSCITATOR W/ POP-OFF 40CM H2O,L TYPE ADAPTER WITH MANOMETER PORT

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, manual, single-use
Primary Device ID04716770245225
NIH Device Record Key978f866d-4c7f-4206-8fb5-cc149cb345d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSINGLE USE CHILD 500ML RESUSCITATOR W/ POP-OFF 40
Version Model NumberRE-24522
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104716770245225 [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 Date2017-12-28

On-Brand Devices [ SINGLE USE CHILD 500ML RESUSCITATOR W/ POP-OFF 40]

04716770255200RE-25520
04716770245225SINGLE USE CHILD 500ML RESUSCITATOR W/ POP-OFF 40CM H2O,L TYPE ADAPTER WITH MANOMETER PORT
04716770245201RE-24520
04716770225258RE-22525
40716770245102RE-24510

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