Catalog Number

-

Brand Name

MAXO2ME

Version/Model Number

R230P01-002

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)

-

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

c49511d2-cd28-43e6-a5b0-4807fd006222

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-