TANITA/Ironman Body Composition Monitor - TANITA CORPORATION

Duns Number:690539978

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More Product Details

Catalog Number

-

Brand Name

TANITA/Ironman Body Composition Monitor

Version/Model Number

BC-549plus

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

MNW

Product Code Name

Analyzer, Body Composition

Device Record Status

Public Device Record Key

9a112be6-68f9-49b9-ba81-a0a63ff0603a

Public Version Date

July 09, 2018

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

14904785817705

Quantity per Package

4

Contains DI Package

04904785817708

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