Catalog Number

-

Brand Name

Medex

Version/Model Number

MX8024

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 13, 2019

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

Yes

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

K070340,K820355,K070340,K820355

Product Code

CBT

Product Code Name

Arterial blood sampling kit

Public Device Record Key

11ee9217-e5a2-41eb-97a8-4a04a499ceaa

Public Version Date

October 08, 2019

Public Version Number

5

DI Record Publish Date

October 13, 2016

Package DI Number

50351688505024

Quantity per Package

10

Contains DI Package

10351688505026

Package Discontinue Date

August 13, 2019

Package Status

Not in Commercial Distribution

Package Type

Case