Catalog Number

-

Brand Name

CURE MEDICAL

Version/Model Number

K1

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OHR

Product Code Name

Catheter Care Tray

Public Device Record Key

8b3d46b3-2f6c-4da7-8794-05a006ec6491

Public Version Date

October 27, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

10815947020465

Quantity per Package

100

Contains DI Package

00815947020468

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case