Catalog Number

K04-01201

Brand Name

Merit Medical®

Version/Model Number

00884450293256

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

5ca22205-4e16-41b2-abc9-05025bae604b

Public Version Date

October 15, 2018

Public Version Number

1

DI Record Publish Date

September 13, 2018

Package DI Number

10884450293253

Quantity per Package

50

Contains DI Package

00884450293256

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-