Catalog Number

-

Brand Name

Withings®

Version/Model Number

WPM05

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

7d9b3685-59d6-47c2-8f18-99c02fdd801e

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

June 17, 2019

Package DI Number

23700546705988

Quantity per Package

12

Contains DI Package

03700546705984

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping carton