Catalog Number

-

Brand Name

CADD

Version/Model Number

21-2140-25

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K130394

Product Code

MEA

Product Code Name

Pump, infusion, pca

Public Device Record Key

0fc1d498-bea0-4bad-9589-f215d229c8d9

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

December 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-