Catalog Number

21-2130-51

Brand Name

CADD

Version/Model Number

2130

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

-

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

K170982

Product Code

MEA

Product Code Name

Pump, infusion, pca

Public Device Record Key

5a353625-3511-4e97-980d-a87f9d9ad1d7

Public Version Date

August 17, 2018

Public Version Number

4

DI Record Publish Date

September 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-