Catalog Number

FAS1160/B

Brand Name

Merit Medical®

Version/Model Number

00884450019221

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

04ee0404-31fa-4142-90d0-5402be922d7d

Public Version Date

April 07, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

20884450019225

Quantity per Package

4

Contains DI Package

10884450019228

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-