Catalog Number

DYNJ902879R

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNJ902879R

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

Yes

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

-

FDA Premarket Submission

-

Product Code

OEZ

Product Code Name

Cardiovascular procedure kit

Public Device Record Key

6b7e2acb-9b33-42b0-bbf1-6ee44b85f7df

Public Version Date

June 21, 2022

Public Version Number

1

DI Record Publish Date

June 11, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-