Catalog Number

-

Brand Name

drive

Version/Model Number

OM-900

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

-

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

NFB

Product Code Name

Conserver, oxygen

Public Device Record Key

ded8b2d7-b305-40ea-ab3e-c35d956bfc34

Public Version Date

August 02, 2022

Public Version Number

3

DI Record Publish Date

July 01, 2020

Package DI Number

50822383274480

Quantity per Package

20

Contains DI Package

00822383274485

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton