Catalog Number

050-87221

Brand Name

Liberty® PDx

Version/Model Number

050-87221

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

FKX

Product Code Name

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Public Device Record Key

48520d32-e909-47d1-ab18-2209af286820

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 02, 2015

Package DI Number

10840861101983

Quantity per Package

10

Contains DI Package

00840861101986

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case