Catalog Number

-

Brand Name

Medex

Version/Model Number

MXG300260

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

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,K942377,K070340,K942377

Product Code

CBT

Product Code Name

Arterial blood sampling kit

Public Device Record Key

a04cb648-fcf0-469d-8a99-560982023982

Public Version Date

July 16, 2018

Public Version Number

5

DI Record Publish Date

October 13, 2016

Package DI Number

50351688518833

Quantity per Package

10

Contains DI Package

10351688518835

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE