Catalog Number

ECVC7885

Brand Name

MEDLINE

Version/Model Number

ECVC7885

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OES

Product Code Name

Cardiac catheterization kit

Public Device Record Key

85c7404f-8394-4488-9dd5-415726ea6631

Public Version Date

May 26, 2022

Public Version Number

1

DI Record Publish Date

May 18, 2022

Package DI Number

00653160353266

Quantity per Package

5

Contains DI Package

10653160353263

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE