Catalog Number

-

Brand Name

drive

Version/Model Number

OM-900M

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

K113111,K113111

Product Code

NFB

Product Code Name

Conserver, oxygen

Public Device Record Key

94ea2a4c-2cd2-4cc4-bc13-b9c41b4c0535

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

July 01, 2020

Package DI Number

50822383283819

Quantity per Package

25

Contains DI Package

00822383283814

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton