Catalog Number

050-87212

Brand Name

Liberty®

Version/Model Number

050-87212

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

K043363,K173718,K043363,K173718

Product Code

FKX

Product Code Name

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Public Device Record Key

eebbbdd4-55fe-4101-9aa4-70cbe1d4f3c5

Public Version Date

March 01, 2021

Public Version Number

4

DI Record Publish Date

October 02, 2015

Package DI Number

10840861100733

Quantity per Package

10

Contains DI Package

00840861100736

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case