MedSource Oxygen Regulator Not Applicable

GUDID 00816703024362

Oxygen Regulator, 0-25 LPM

MEDSOURCE INTERNATIONAL LLC

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Primary Device ID00816703024362
NIH Device Record Key7fa61cdc-ea05-4bc4-8515-0efb0d5bf207
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedSource Oxygen Regulator
Version Model NumberMS-010R253
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816703024355 [Primary]
GS100816703024362 [Package]
Contains: 00816703024355
Package: Case [20 Units]
In Commercial Distribution
GS100840155411692 [Package]
Contains: 00816703024355
Package: Box [1 Units]
In Commercial Distribution

FDA Product Code

CANRegulator, Pressure, Gas Cylinder

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-04
Device Publish Date2021-04-26

On-Brand Devices [MedSource Oxygen Regulator]

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00816703024348Oxygen Regulator, Brass, 0-25 LPM
00816703024317Oxygen Regulator, Aluminum, 0-15 LPM
00816703024447Oxygen Regulator, Brass, 0-25 LPM
00816703024416D-TANK REGULATOR

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