Liberty® Select Cycler

GUDID 00840861102068

Liberty® Select Cycler

Fresenius Usa, Inc.

Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system

• Primary Device ID: 00840861102068
• NIH Device Record Key: b6169658-7d4b-43b3-a5ad-4f8c3822ccef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Liberty® Select Cycler
• Version Model Number: 180343
• Company DUNS: 076594100
• Company Name: Fresenius Usa, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Device Dimensions

• Device Size Text, specify: 0
• Weight: 32 Pound
• Device Size Text, specify: 0
• Weight: 32 Pound
• Device Size Text, specify: 0
• Weight: 32 Pound
• Device Size Text, specify: 0
• Weight: 32 Pound
• Device Size Text, specify: 0
• Weight: 32 Pound
• Device Size Text, specify: 0
• Weight: 32 Pound
• Device Size Text, specify: 0
• Weight: 32 Pound
• Device Size Text, specify: 0
• Weight: 32 Pound
• Device Size Text, specify: 0
• Weight: 32 Pound
• Device Size Text, specify: 0
• Weight: 32 Pound
• Device Size Text, specify: 0
• Weight: 32 Pound
• Device Size Text, specify: 0
• Weight: 32 Pound
• Device Size Text, specify: 0
• Weight: 32 Pound
• Device Size Text, specify: 0
• Weight: 32 Pound
• Device Size Text, specify: 0
• Weight: 32 Pound
• Device Size Text, specify: 0
• Weight: 32 Pound
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861102068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171652

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-26

Devices Manufactured by Fresenius Usa, Inc.

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• 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