Catalog Number

-

Brand Name

O2-MAX

Version/Model Number

313-8007X

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

BYE

Product Code Name

Attachment, Breathing, Positive End Expiratory Pressure

Public Device Record Key

575f2081-e1db-4c66-9251-9f3f217f68c0

Public Version Date

November 11, 2019

Public Version Number

5

DI Record Publish Date

January 22, 2016

Package DI Number

10841470102194

Quantity per Package

10

Contains DI Package

00841470102197

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-