Catalog Number

-

Brand Name

Fitfaith

Version/Model Number

M170E

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 15, 2019

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PGJ

Product Code Name

Oximeter, Wellness

Public Device Record Key

6b380b16-16c0-4a33-837b-e2e3619799a0

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

May 15, 2018

Package DI Number

16970953260077

Quantity per Package

100

Contains DI Package

06970953260070

Package Discontinue Date

May 15, 2019

Package Status

Not in Commercial Distribution

Package Type

-