Catalog Number

28MC21110SN/B

Brand Name

Merit Maestro®

Version/Model Number

00884450335222

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

KRA

Product Code Name

Catheter, continuous flush

Public Device Record Key

9b878880-ebd7-4ff8-a706-827c74699a6e

Public Version Date

October 11, 2021

Public Version Number

4

DI Record Publish Date

June 04, 2018

Package DI Number

10884450335229

Quantity per Package

20

Contains DI Package

00884450335222

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-