Catalog Number

K14-00016A

Brand Name

Merit® Kit

Version/Model Number

00884450137444

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

MSD

Product Code Name

Catheter, hemodialysis, implanted

Public Device Record Key

66ef3af0-364d-4e22-9035-191e05b04e58

Public Version Date

October 11, 2021

Public Version Number

5

DI Record Publish Date

September 20, 2016

Package DI Number

10884450137441

Quantity per Package

4

Contains DI Package

00884450137444

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-