Catalog Number

-

Brand Name

physIQ Personalized Physiology Analytics Engine

Version/Model Number

2

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

K142512

Product Code

PLB

Product Code Name

Multivariate Vital Signs Index

Public Device Record Key

bcfaef78-f7c2-4828-8f1b-8786ddc198b9

Public Version Date

January 18, 2022

Public Version Number

1

DI Record Publish Date

January 10, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-