Catalog Number

K08-03297

Brand Name

Merit Medical®

Version/Model Number

00884450653319

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

3a6bee26-4189-486b-9e82-e9d5cc4c923d

Public Version Date

March 25, 2022

Public Version Number

1

DI Record Publish Date

March 17, 2022

Package DI Number

10884450653316

Quantity per Package

10

Contains DI Package

00884450653319

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-