TANITA/FitScan Body Composition Monitor - TANITA CORPORATION

Duns Number:690539978

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More Product Details

Catalog Number

BC-603FS MB

Brand Name

TANITA/FitScan Body Composition Monitor

Version/Model Number

BC-603FS

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

ae50bf56-b803-4b35-9d8b-6a1e8b1dacc1

Public Version Date

November 27, 2020

Public Version Number

1

DI Record Publish Date

November 19, 2020

Additional Identifiers

Package DI Number

14904785047669

Quantity per Package

4

Contains DI Package

04904785047662

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