Catalog Number

PAKM4NPD7/B

Brand Name

Merit PAK™

Version/Model Number

00884450587133

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

DRE

Product Code Name

DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Public Device Record Key

b2efbfa4-161b-4ab6-9eda-9d307ce51b3c

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

December 31, 2021

Package DI Number

10884450587130

Quantity per Package

5

Contains DI Package

00884450587133

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-