Portal 724 - Optum Home Scale I-ICUE - OPTUMHEALTH CARE SOLUTIONS, INC.

Duns Number:078270206

Device Description: Optum Home Scale I-ICUE

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

AAA-85009

Brand Name

Portal 724

Version/Model Number

EM724BT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FRI

Product Code Name

SCALE, STAND-ON, PATIENT

Device Record Status

Public Device Record Key

3e1255e5-bc73-4c12-8a72-f7f09ddda4ef

Public Version Date

August 11, 2021

Public Version Number

2

DI Record Publish Date

December 07, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OPTUMHEALTH CARE SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 3