Catalog Number

-

Brand Name

Newport Medical

Version/Model Number

OM1001P

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 23, 2021

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

K973282

Product Code

CCL

Product Code Name

ANALYZER, GAS, OXYGEN, GASEOUS-PHASE

Public Device Record Key

07afa126-7952-48b4-be58-455d3f3f8535

Public Version Date

March 08, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-