TANITA/FitScan Body Composition Monitor - TANITA CORPORATION

Duns Number:690539978

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More Product Details

Catalog Number

BC-577F NS

Brand Name

TANITA/FitScan Body Composition Monitor

Version/Model Number

BC-577F

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

PUH

Product Code Name

Analyzer, Body Composition, Exempt

Device Record Status

Public Device Record Key

6ab9e98f-9148-4be6-b7a9-009fb4815abb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 19, 2016

Additional Identifiers

Package DI Number

14904785817996

Quantity per Package

4

Contains DI Package

04904785817999

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"TANITA CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 47