Catalog Number

-

Brand Name

TANITA/FitScan Body Composition Monitor

Version/Model Number

BC-545 F

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)

-

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

b0592aff-9d56-4614-9f5f-c32f77be732c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 15, 2016

Package DI Number

14904785817880

Quantity per Package

4

Contains DI Package

04904785817883

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-