Catalog Number

470616

Brand Name

O2-Sensor

Version/Model Number

M-16HT

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

-

Product Code

CCL

Product Code Name

Analyzer, Gas, Oxygen, Gaseous-Phase

Public Device Record Key

b7a3be80-5e5d-45ac-88bc-41944c601d69

Public Version Date

September 15, 2021

Public Version Number

1

DI Record Publish Date

September 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-