NIH™ Cardio-Marker - WVN CATH 010010 5F 5PK 65 PEDI NIH - MEDTRONIC, INC.

Duns Number:006261481

Device Description: WVN CATH 010010 5F 5PK 65 PEDI NIH

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More Product Details

Catalog Number

-

Brand Name

NIH™ Cardio-Marker

Version/Model Number

010010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Device Record Status

Public Device Record Key

46863e25-0f7f-4c15-a033-db34a9875dc1

Public Version Date

March 06, 2019

Public Version Number

1

DI Record Publish Date

February 03, 2019

Additional Identifiers

Package DI Number

20763000200002

Quantity per Package

5

Contains DI Package

00763000200008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK

"MEDTRONIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 102
2 A medical device with a moderate to high risk that requires special controls. 20495
3 A medical device with high risk that requires premarket approval 3601