Catalog Number

DYNJ40897

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNJ40897

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

OES

Product Code Name

Cardiac catheterization kit

Public Device Record Key

d9465640-8e85-417d-a64b-7bde6158efae

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

September 29, 2016

Package DI Number

40884389901121

Quantity per Package

4

Contains DI Package

10884389901120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE