Catalog Number

K06-00334

Brand Name

Merit Medical®

Version/Model Number

00884450431849

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

K163084,K163084,K163084

Product Code

DXT

Product Code Name

INJECTOR AND SYRINGE, ANGIOGRAPHIC

Public Device Record Key

20b47fee-55cb-4ef6-ac44-fe50661d1878

Public Version Date

July 26, 2019

Public Version Number

1

DI Record Publish Date

July 18, 2019

Package DI Number

10884450431846

Quantity per Package

25

Contains DI Package

00884450431849

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-