Catalog Number

K09-11108B

Brand Name

Merit Medical®

Version/Model Number

00884450699300

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

1a379996-39a2-44eb-8395-9d5fd8fe2260

Public Version Date

October 14, 2022

Public Version Number

1

DI Record Publish Date

October 06, 2022

Package DI Number

10884450699307

Quantity per Package

10

Contains DI Package

00884450699300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-