AccessGUDID - DEVICE: Liberty® (00840861100750)

GUDID

Device Identifier (DI) Information

Brand Name: Liberty®
Version or Model: 050-87216
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 050-87216
Company Name: Fresenius Medical Care Holdings, Inc.

Primary DI Number: 00840861100750
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 958291411 *Terms of Use

Device Description: Liberty Cycler Set, One patient connector with extended patient and drain lines

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35000	Peritoneal dialysis system tubing set	A sterile set intended for the administration of peritoneal dialysis. It will typically consist of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysis filter to trap and remove contaminating particles. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FKX	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K043363	000
K173718	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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