Catalog Number

R230P01

Brand Name

MAXO2 ME

Version/Model Number

R230P01

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

K153659

Product Code

CCL

Product Code Name

Analyzer, Gas, Oxygen, Gaseous-Phase

Public Device Record Key

09bacd53-f024-46f9-a300-51c00a7596bf

Public Version Date

December 21, 2018

Public Version Number

4

DI Record Publish Date

July 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-