Catalog Number

FAS5108/A

Brand Name

Merit Medical®

Version/Model Number

00884450019252

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

K915678,K915678,K915678

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

3a6dd8a3-7d2f-48c7-89bc-1ab8fe972344

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

December 05, 2016

Package DI Number

10884450019259

Quantity per Package

25

Contains DI Package

00884450019252

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-