Catalog Number

-

Brand Name

CADD

Version/Model Number

21-7115-24

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

K000942,K000942

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

f279399c-d615-46a3-bb7c-1c4c4a06c0a5

Public Version Date

November 14, 2019

Public Version Number

5

DI Record Publish Date

November 16, 2016

Package DI Number

30610586034507

Quantity per Package

12

Contains DI Package

10610586034503

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box