RESUSCITATOR MANOMETER POP OFF CHILD

GUDID 04716770214542

BESMED HEALTH BUSINESS CORP.

Airway pressure monitor, non-powered
Primary Device ID04716770214542
NIH Device Record Keye7fc9099-f91c-461b-835e-04548fe7afa0
Commercial Distribution StatusIn Commercial Distribution
Brand NameRESUSCITATOR MANOMETER POP OFF CHILD
Version Model NumberRE-21454
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
GS104716770214542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)

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

On-Brand Devices [RESUSCITATOR MANOMETER POP OFF CHILD]

04716770214641RE-21464
04716770214542RE-21454

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