Catalog Number

-

Brand Name

Cardiovascular Procedure Kit

Version/Model Number

64345

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)

Yes

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

-

Product Code Name

-

Public Device Record Key

28d8b1a2-9a1d-4dd2-97f6-5d8277b25ad8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 01, 2014

Package DI Number

50699753456384

Quantity per Package

10

Contains DI Package

00699753456389

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

10 Piece Case