Catalog Number

-

Brand Name

Kintinuum™

Version/Model Number

MC-0011

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 01, 2021

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ISD

Product Code Name

Exerciser, Measuring

Public Device Record Key

4b7fcc20-971a-4c6c-9b18-2b14f9fb6d96

Public Version Date

April 02, 2021

Public Version Number

3

DI Record Publish Date

February 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-