Catalog Number

-

Brand Name

Withings®

Version/Model Number

WBS05-Pastel Sand

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

26de5cc1-42c5-4901-a492-15d93855771b

Public Version Date

February 28, 2020

Public Version Number

2

DI Record Publish Date

October 31, 2018

Package DI Number

13700546705080

Quantity per Package

4

Contains DI Package

03700546705083

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

master case