MedSource Disposable Resuscitator, Adult (10/cs)

GUDID 00816703021286

Disposable Resuscitator, Adult (10/cs)

MEDSOURCE INTERNATIONAL LLC

Pulmonary resuscitator, manual, single-use
Primary Device ID00816703021286
NIH Device Record Key691416ec-f73a-467b-aa69-014b75b06894
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedSource Disposable Resuscitator, Adult (10/cs)
Version Model NumberMS-6210
Company DUNS041674552
Company NameMEDSOURCE INTERNATIONAL LLC
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
GS100816703021286 [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 Date2016-07-14

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