Catalog Number

-

Brand Name

Body Composition Scale

Version/Model Number

eF-670W

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

Yes

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

12a35788-e12d-41c7-8872-37472cd79e59

Public Version Date

July 27, 2021

Public Version Number

1

DI Record Publish Date

July 19, 2021

Package DI Number

16974239700387

Quantity per Package

1

Contains DI Package

06974239700380

Package Discontinue Date

July 19, 2021

Package Status

Not in Commercial Distribution

Package Type

BOX