Catalog Number

10430L-BLUE

Brand Name

Acc U Rate

Version/Model Number

400B Blue

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 07, 2017

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

DQA

Product Code Name

Oximeter

Public Device Record Key

96d27c39-cae4-4ddf-905d-2780568353fc

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

December 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-