Catalog Number

026-20036A

Brand Name

Liberty®

Version/Model Number

026-20036A

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

-

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

-

FDA Premarket Submission

K043363,K915628,K043363,K915628

Product Code

FKX

Product Code Name

System, Peritoneal, Automatic Delivery

Public Device Record Key

4c48234d-875f-45a9-b51e-37d9de9f8f5e

Public Version Date

March 02, 2021

Public Version Number

4

DI Record Publish Date

October 02, 2015

Package DI Number

10840861101112

Quantity per Package

30

Contains DI Package

00840861101115

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case