Catalog Number

CK-3NC

Brand Name

NEOMED*

Version/Model Number

CK-3NC

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

KYX

Product Code Name

DISPENSER, LIQUID MEDICATION

Public Device Record Key

8d6a3e30-0b16-4bba-b35c-a3b5ea6df880

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

August 27, 2021

Package DI Number

10350770003266

Quantity per Package

50

Contains DI Package

00350770003269

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS