Catalog Number

K14-00067

Brand Name

Merit® Kit

Version/Model Number

00884450322451

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

PEV

Product Code Name

Dialysis administration kit

Public Device Record Key

8ea2a860-1b7d-41c3-97d0-82a4f48941bc

Public Version Date

October 15, 2018

Public Version Number

1

DI Record Publish Date

September 13, 2018

Package DI Number

10884450322458

Quantity per Package

30

Contains DI Package

00884450322451

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-