Catalog Number

DYKA1119A

Brand Name

Medline Industries, Inc.

Version/Model Number

DYKA1119A

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

-

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

-

FDA Premarket Submission

K001872

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

c2d04a58-b8e2-46cb-ae9a-1f119f9bad64

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

July 27, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-