Catalog Number

-

Brand Name

WITHINGS

Version/Model Number

BP-801

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

d78332f9-72b8-4d94-a0d8-81c182973e70

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

October 07, 2016

Package DI Number

14719873310026

Quantity per Package

10

Contains DI Package

04719873310029

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-