Catalog Number

-

Brand Name

Oximeter

Version/Model Number

G1B Plus

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

K082789,K082789

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

b2eec611-341d-4347-ab96-5dc3e9464ead

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

December 19, 2016

Package DI Number

06938368100039

Quantity per Package

1

Contains DI Package

06938368100022

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-