Catalog Number

K09-12181F

Brand Name

Merit Medical®

Version/Model Number

00884450683552

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

a77222d9-5874-4098-a50c-66dc4a6f13d5

Public Version Date

August 26, 2022

Public Version Number

1

DI Record Publish Date

August 18, 2022

Package DI Number

20884450683556

Quantity per Package

2

Contains DI Package

10884450683559

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-