Catalog Number

-

Brand Name

Beurer

Version/Model Number

BF350

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

f9f1ba8d-9cd4-4245-9f52-9e9c037835e0

Public Version Date

February 25, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10852547004556

Quantity per Package

4

Contains DI Package

00852547004559

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack