Catalog Number

0483148

Brand Name

Lifecare PCA

Version/Model Number

0483148

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

-

Product Code

MEA

Product Code Name

Pump, infusion, pca

Public Device Record Key

e8d3ba0e-0f22-4984-a5a4-bcd98f128e02

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 01, 2016

Package DI Number

20887787005039

Quantity per Package

48

Contains DI Package

10887787005032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Corrugated Box