Catalog Number

K09-10938B

Brand Name

Merit Medical®

Version/Model Number

00884450696910

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

dc1cf13c-e172-4e73-b2a2-062d23a02968

Public Version Date

September 22, 2022

Public Version Number

1

DI Record Publish Date

September 14, 2022

Package DI Number

20884450696914

Quantity per Package

2

Contains DI Package

10884450696917

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-