Catalog Number

-

Brand Name

Body Composition Scale

Version/Model Number

eF-919B4S

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)

Yes

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

c14336c1-a9ee-4ed4-a413-c0a2438a79db

Public Version Date

July 27, 2021

Public Version Number

1

DI Record Publish Date

July 19, 2021

Package DI Number

16974239700134

Quantity per Package

1

Contains DI Package

06974239700137

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX