Catalog Number

-

Brand Name

Withings®

Version/Model Number

WBS05-White

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

PUH

Product Code Name

Analyzer, Body Composition, Exempt

Public Device Record Key

31ed2e5b-3ef5-462a-8345-3e859c0effaa

Public Version Date

February 28, 2020

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

13700546701068

Quantity per Package

4

Contains DI Package

03700546701061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

master case