Catalog Number

-

Brand Name

Withings®

Version/Model Number

HWA09

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DPS

Product Code Name

Electrocardiograph

Public Device Record Key

8c7f501a-aa2b-41e2-91be-f4068bf80aac

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

October 12, 2021

Package DI Number

13700546706407

Quantity per Package

10

Contains DI Package

03700546706400

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

master case