Catalog Number

Art. No. 749.75

Brand Name

InnoHaus

Version/Model Number

ABF220

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

6e919a8d-47e5-4e53-9b9c-f6a75ed2065c

Public Version Date

February 25, 2019

Public Version Number

2

DI Record Publish Date

December 10, 2018

Package DI Number

10853879007796

Quantity per Package

4

Contains DI Package

00853879007799

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack