Catalog Number

-

Brand Name

CADD

Version/Model Number

21-7361-24

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

K031361,K031361

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

ed297097-21b7-4f7f-8c43-0e5751832372

Public Version Date

October 21, 2020

Public Version Number

2

DI Record Publish Date

March 06, 2020

Package DI Number

35019517191732

Quantity per Package

15

Contains DI Package

15019517191738

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case