Catalog Number

K08-03276

Brand Name

Merit Medical®

Version/Model Number

00884450551950

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

f1b35c22-542e-4296-9825-c61d0f8d3f0c

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

February 16, 2021

Package DI Number

20884450551954

Quantity per Package

4

Contains DI Package

10884450551957

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-