Catalog Number

Not Applicable

Brand Name

MedSource O2 Cylinder

Version/Model Number

MS-MED-M2

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

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

CAN

Product Code Name

Regulator, Pressure, Gas Cylinder

Public Device Record Key

2c84f1f6-c590-4fec-9436-90889ec29964

Public Version Date

August 13, 2021

Public Version Number

1

DI Record Publish Date

August 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-