Catalog Number

K09-11872C

Brand Name

Merit Medical®

Version/Model Number

00884450684597

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

e4e5fb1c-a997-41aa-8d73-d3443498e65f

Public Version Date

August 15, 2022

Public Version Number

1

DI Record Publish Date

August 06, 2022

Package DI Number

10884450684594

Quantity per Package

10

Contains DI Package

00884450684597

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-