Catalog Number

CK-3

Brand Name

NEOMED*

Version/Model Number

CK-3

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

3cf2234f-938d-40d2-b1db-318a7fbb0c35

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 27, 2021

Package DI Number

10350770003235

Quantity per Package

50

Contains DI Package

00350770003238

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS