Optiflux® Ultra

GUDID 10840861100191

F180 Optiflux Ultra Dialyzer / High Flux / Polysulfone / 1.6 m2 / Ebeam / Single Use / 89 mL

Fresenius Medical Care Holdings, Inc.

Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use

• Primary Device ID: 10840861100191
• NIH Device Record Key: 426a5511-c43b-4f2d-9ef6-a49b1e72efaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optiflux® Ultra
• Version Model Number: 0500418E
• 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: true
• 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

Device Dimensions

• Area/Surface Area: 1.6 Square meter
• Area/Surface Area: 1.6 Square meter
• Area/Surface Area: 1.6 Square meter
• Area/Surface Area: 1.6 Square meter
• Area/Surface Area: 1.6 Square meter
• Area/Surface Area: 1.6 Square meter
• Area/Surface Area: 1.6 Square meter
• Area/Surface Area: 1.6 Square meter
• Area/Surface Area: 1.6 Square meter
• Area/Surface Area: 1.6 Square meter
• Area/Surface Area: 1.6 Square meter
• Area/Surface Area: 1.6 Square meter
• Area/Surface Area: 1.6 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861100194 [Primary]
GS1	10840861100191 [Package]; Contains: 00840861100194; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123262

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: 2018-12-03
• Device Publish Date: 2015-09-24

On-Brand Devices [Optiflux® Ultra]

• 10840861100214: F210 Optiflux Ultra Dialyzer / High Flux / Polysulfone / 2.2 m2 / Ebeam / Single Use / 124 mL
• 10840861100207: F190 Optiflux Ultra Dialyzer / High Flux / Polysulfone / 1.9 m2 / Ebeam / Single Use / 105 mL
• 10840861100191: F180 Optiflux Ultra Dialyzer / High Flux / Polysulfone / 1.6 m2 / Ebeam / Single Use / 89 mL
• 10840861100184: F160 Optiflux Ultra Dialyzer / High Flux / Polysulfone / 1.4 m2 / Ebeam / Single Use / 77 mL