Catalog Number

-

Brand Name

physIQ Android App

Version/Model Number

3.4 (Edison)

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

Yes

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

OUG

Product Code Name

Medical Device Data System

Public Device Record Key

f4bcb1c4-e06e-40c1-a896-7b9803f04589

Public Version Date

October 19, 2020

Public Version Number

1

DI Record Publish Date

October 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-