Catalog Number

-

Brand Name

PED NIH™ Cardio-Marker

Version/Model Number

990804

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

4d75e87e-6a1e-4aea-94c9-aa1799b0c58b

Public Version Date

March 06, 2019

Public Version Number

1

DI Record Publish Date

February 03, 2019

Package DI Number

20763000200217

Quantity per Package

5

Contains DI Package

00763000200213

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK