Liberty® Select Cycler

GUDID 00840861102068

Liberty® Select Cycler

Fresenius Usa, Inc.

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
• 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
• 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

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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