Duns Number:958291411
Device Description: Liberty Cycler Set, One patient connector with extended patient and drain lines
Catalog Number
050-87216
Brand Name
Liberty®
Version/Model Number
050-87216
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
f538bec5-be12-4b90-b15a-aa544a09ef35
Public Version Date
March 01, 2021
Public Version Number
5
DI Record Publish Date
October 02, 2015
Package DI Number
10840861100757
Quantity per Package
10
Contains DI Package
00840861100750
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 65 |