Catalog Number

K04-01212

Brand Name

Merit Medical®

Version/Model Number

00816777026712

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

OJA

Product Code Name

Intravenous extension tubing set

Public Device Record Key

e7efc7f1-2616-4bac-899a-0ed076bbe704

Public Version Date

July 30, 2019

Public Version Number

1

DI Record Publish Date

July 22, 2019

Package DI Number

10816777026719

Quantity per Package

36

Contains DI Package

00816777026712

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-