Catalog Number

-

Brand Name

NIH™ Cardio-Marker

Version/Model Number

010011

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

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

-

Product Code

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Public Device Record Key

2892b725-cd3e-4ba5-83e7-83048cb83c2b

Public Version Date

March 06, 2019

Public Version Number

1

DI Record Publish Date

February 03, 2019

Package DI Number

20763000200019

Quantity per Package

5

Contains DI Package

00763000200015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK