Optiflux®

GUDID 10840861100108

F200A Optiflux Dialyzer / High Flux / Polysulfone / 2.0 m2 / ETO / Multiple Use / 113 mL

Fresenius Medical Care Holdings, Inc.

Hollow-fibre haemodialysis dialyser, reusable

• Primary Device ID: 10840861100108
• NIH Device Record Key: 7a8606dd-198f-4608-b4bb-f527023d9986
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optiflux®
• Version Model Number: 0500320A
• Company DUNS: 958291411
• Company Name: Fresenius Medical Care Holdings, 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx

Device Dimensions

• Area/Surface Area: 2 Square meter
• Area/Surface Area: 2 Square meter
• Area/Surface Area: 2 Square meter
• Area/Surface Area: 2 Square meter
• Area/Surface Area: 2 Square meter
• Area/Surface Area: 2 Square meter
• Area/Surface Area: 2 Square meter
• Area/Surface Area: 2 Square meter
• Area/Surface Area: 2 Square meter
• Area/Surface Area: 2 Square meter
• Area/Surface Area: 2 Square meter
• Area/Surface Area: 2 Square meter
• Area/Surface Area: 2 Square meter
• Area/Surface Area: 2 Square meter
• Area/Surface Area: 2 Square meter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861100101 [Primary]
GS1	10840861100108 [Package]; Contains: 00840861100101; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003498

FDA Product Code

• KDI: Dialyzer, high permeability with or without sealed dialysate system

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-10-22
• Device Publish Date: 2015-09-24

On-Brand Devices [Optiflux®]

• 10840861100177: F250NR Optiflux Dialyzer / High Flux / Polysulfone / 2.5 m2 / Ebeam / Single Use / 142 mL
• 10840861100160: F200NR Optiflux Dialyzer / High Flux / Polysulfone / 1.9 m2 / Ebeam / Single Use / 113 mL
• 10840861100153: F180NR Optiflux Dialyzer / High Flux / Polysulfone / 1.7 m2 / Ebeam / Single Use / 102 mL
• 10840861100146: F160NR Optiflux Dialyzer / High Flux / Polysulfone / 1.5 m2 / Ebeam / Single Use / 87 mL
• 10840861100139: F200NR Optiflux Dialyzer / High Flux / Polysulfone / 2.0 m2 / ETO / Single Use / 113 mL
• 10840861100122: F180NR Optiflux Dialyzer / High Flux / Polysulfone / 1.8 m2 / ETO / Single Use / 105 mL
• 10840861100115: F160NR Optiflux Dialyzer / High Flux / Polysulfone / 1.5 m2 / ETO / Single Use / 84 mL
• 10840861100108: F200A Optiflux Dialyzer / High Flux / Polysulfone / 2.0 m2 / ETO / Multiple Use / 113 mL
• 10840861100092: F180A Optiflux Dialyzer / High Flux / Polysulfone / 1.8 m2 / ETO / Multiple Use / 99 mL
• 10840861100085: F18NR Optiflux Dialyzer / Low Flux / Polysulfone / 1.8 m2 / Ebeam / Single Use / 103 mL
• 10840861100078: F16NR Optiflux Dialyzer / Low Flux / Polysulfone / 1.5 m2 / Ebeam / Single Use / 84 mL