Catalog Number

K16-00012

Brand Name

Merit Medical®

Version/Model Number

00884450256084

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

OWL

Product Code Name

Peripheral catheter insertion kit

Public Device Record Key

809d62c0-466b-4371-aa5f-72c52083ba2e

Public Version Date

March 21, 2019

Public Version Number

2

DI Record Publish Date

September 21, 2018

Package DI Number

10884450256081

Quantity per Package

25

Contains DI Package

00884450256084

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-