MedSource Oxygen Mask - Oxygen Mask, Medium O2, Elongated - MEDSOURCE INTERNATIONAL LLC

Duns Number:041674552

Device Description: Oxygen Mask, Medium O2, Elongated

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More Product Details

Catalog Number

Not Applicable

Brand Name

MedSource Oxygen Mask

Version/Model Number

MS-26041-RCS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

BYG

Product Code Name

Mask, Oxygen

Device Record Status

Public Device Record Key

eb6d88ee-08a3-44db-9592-7e928f7795e7

Public Version Date

November 01, 2021

Public Version Number

2

DI Record Publish Date

May 28, 2021

Additional Identifiers

Package DI Number

00840155400382

Quantity per Package

50

Contains DI Package

00840155400375

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"MEDSOURCE INTERNATIONAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 498
2 A medical device with a moderate to high risk that requires special controls. 90