Catalog Number

Not Applicable

Brand Name

MedSource Oxygen Regulator

Version/Model Number

MS-010R15

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

For Single-Use

-

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

CAN

Product Code Name

Regulator, Pressure, Gas Cylinder

Public Device Record Key

0f74d0d8-fb98-4047-a5c6-25042e05f17e

Public Version Date

November 17, 2021

Public Version Number

2

DI Record Publish Date

April 26, 2021

Package DI Number

00816703024317

Quantity per Package

20

Contains DI Package

00816703024300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case