Liberty® PDx

GUDID 00840861100989

Liberty® PDx CYCLER

Fresenius Usa, Inc.

Peritoneal dialysis system

• Primary Device ID: 00840861100989
• NIH Device Record Key: 82ae7c2f-cebc-4ebd-81d2-b35569771c30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Liberty® PDx
• Version Model Number: 180237
• Company DUNS: 076594100
• Company Name: Fresenius Usa, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)227-2572
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Temperature: Between 31 Degrees Celsius and 54 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861100989 [Primary]

FDA Product Code

• FKX: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-02

Devices Manufactured by Fresenius Usa, Inc.

• 00840861102280 - VersiPD: 2023-08-09 VersiPD Cart
• 00840861102198 - VersiPD: 2023-02-22 VersiPD Cycler
• 00840861102297 - VersiPD: 2023-02-22 VersiPD Dialysate Solution Bag Case
• 00840861100897 - 2008® Series Hemodialysis Machines: 2018-07-06 2008T HEMODIALYSIS SYS., with CDX
• 00840861100903 - 2008® Series Hemodialysis Machines: 2018-07-06 2008T HEMODIALYSIS SYSTEM WITHOUT CDX
• 00840861100934 - 2008® Series Hemodialysis Machines: 2018-07-06 2008T HD SYSTEM WITH CDX, CANADA
• 00840861100941 - 2008® Series Hemodialysis Machines: 2018-07-06 2008K@HOME HEMODIALYSIS SYSTEM
• 00840861100965 - 2008® Series Hemodialysis Machines: 2018-07-06 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG