Catalog Number

-

Brand Name

Medex

Version/Model Number

22-7500

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"

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

ION

Product Code Name

EXERCISER, NON-MEASURING

Public Device Record Key

60c9f992-fc57-4578-8b2d-016f2394585b

Public Version Date

September 14, 2020

Public Version Number

2

DI Record Publish Date

December 18, 2019

Package DI Number

50788942275001

Quantity per Package

10

Contains DI Package

00788942275006

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case