Catalog Number

-

Brand Name

Body Composition Scale

Version/Model Number

EF-805B4

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

fc5da272-a482-4cca-86a5-cfeff9af2474

Public Version Date

July 26, 2021

Public Version Number

1

DI Record Publish Date

July 16, 2021

Package DI Number

16974239700172

Quantity per Package

1

Contains DI Package

06974239700175

Package Discontinue Date

July 16, 2021

Package Status

Not in Commercial Distribution

Package Type

BOX