Catalog Number

-

Brand Name

OxyGo Inline Water Trap, For Oxygen Delivery

Version/Model Number

1425-1013

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"

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

K954271,K954271

Product Code

CAW

Product Code Name

Generator, Oxygen, Portable

Public Device Record Key

4f7762b9-737c-45da-afca-2104122d77fb

Public Version Date

October 26, 2018

Public Version Number

1

DI Record Publish Date

September 25, 2018

Package DI Number

10709078005944

Quantity per Package

25

Contains DI Package

00709078005947

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-