Catalog Number

K01-07810

Brand Name

Merit Medical®

Version/Model Number

00884450249802

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

FMF

Product Code Name

Syringe, piston

Public Device Record Key

5fb865d8-f819-4425-a58f-1e9874547ff3

Public Version Date

April 08, 2021

Public Version Number

1

DI Record Publish Date

March 31, 2021

Package DI Number

20884450249806

Quantity per Package

4

Contains DI Package

10884450249809

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-