Catalog Number

-

Brand Name

Balance

Version/Model Number

S-4

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

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

13b31376-8d26-4bf2-a627-b27ead1a251a

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

January 15, 2019

Package DI Number

10863398000260

Quantity per Package

4

Contains DI Package

00863398000263

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton