Catalog Number

-

Brand Name

CADD

Version/Model Number

21-7363-24

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

b51fe5a3-2359-4f31-b79e-5a92a110a2d0

Public Version Date

March 27, 2020

Public Version Number

1

DI Record Publish Date

March 19, 2020

Package DI Number

35019517161964

Quantity per Package

15

Contains DI Package

15019517161960

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box