Health-O-Meter - Body Fat Monitoring Scale - Jarden Consumer Solutions

Duns Number:001315134

Device Description: Body Fat Monitoring Scale

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More Product Details

Catalog Number

-

Brand Name

Health-O-Meter

Version/Model Number

080006111955

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

4d67e4db-dfd0-4512-a591-a8b5ba38e9c5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 23, 2018

Additional Identifiers

Package DI Number

20080006111959

Quantity per Package

2

Contains DI Package

00080006111955

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"JARDEN CONSUMER SOLUTIONS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 23
2 A medical device with a moderate to high risk that requires special controls. 164