MedSource Oxygen Mask Not Applicable

GUDID 00840155400382

Oxygen Mask, Medium O2, Elongated

MEDSOURCE INTERNATIONAL LLC

Rebreathing oxygen face mask
Primary Device ID00840155400382
NIH Device Record Keyeb6d88ee-08a3-44db-9592-7e928f7795e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedSource Oxygen Mask
Version Model NumberMS-26041-RCS
Catalog NumberNot Applicable
Company DUNS041674552
Company NameMEDSOURCE INTERNATIONAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
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
GS100840155400375 [Primary]
GS100840155400382 [Package]
Contains: 00840155400375
Package: Case [50 Units]
In Commercial Distribution

FDA Product Code

BYGMask, Oxygen

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-11-01
Device Publish Date2021-05-28

On-Brand Devices [MedSource Oxygen Mask]

00840155400443Oxygen Mask, Medium O2, Infant U. Conn.
00840155400412Oxygen Mask, Medium O2, Pediatric
00840155400405Oxygen Mask, Medium O2, Pediatric
00840155400382Oxygen Mask, Medium O2, Elongated
00840155411647"Medium Concentration Oxygen Mask Universal Connector, Pediatric "

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