Catalog Number

B100-IOW

Brand Name

QardioBase

Version/Model Number

B100

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MNW

Product Code Name

Analyzer, Body Composition

Public Device Record Key

972ce8f0-032e-4232-94b5-ead3a198b695

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

10854894005170

Quantity per Package

4

Contains DI Package

00854894005173

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Masterbox