Catalog Number

-

Brand Name

CADD

Version/Model Number

21-2188-25

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

-

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

K080743,K080743

Product Code

FRN

Product Code Name

Pump, infusion

Public Device Record Key

91c6bc1d-2233-4fdc-a9be-e6941a8e96c5

Public Version Date

April 21, 2021

Public Version Number

7

DI Record Publish Date

October 13, 2016

Package DI Number

10610586031878

Quantity per Package

1

Contains DI Package

10610586035029

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

EACH