Catalog Number

0602103

Brand Name

PCA

Version/Model Number

602103

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

MEA

Product Code Name

Pump, infusion, pca

Public Device Record Key

95dae3c0-ea15-4f59-8700-328e4815982e

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

20887787001901

Quantity per Package

25

Contains DI Package

10887787001904

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case