Catalog Number

-

Brand Name

Fitfaith

Version/Model Number

M230

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2020

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

K163135,K163135

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

c9f1e0b6-80e2-4e62-b7d6-86375b03fdbb

Public Version Date

November 10, 2021

Public Version Number

6

DI Record Publish Date

May 15, 2018

Package DI Number

16970953260046

Quantity per Package

100

Contains DI Package

06970953260049

Package Discontinue Date

December 31, 2020

Package Status

Not in Commercial Distribution

Package Type

-