Catalog Number

B200-IVB

Brand Name

QardioBase 2

Version/Model Number

B200

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

PUH

Product Code Name

Analyzer, Body Composition, Exempt

Public Device Record Key

3725ac82-1d86-4470-86f4-ae918d261e01

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 31, 2017

Package DI Number

10854894005231

Quantity per Package

4

Contains DI Package

00854894005234

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Masterbox