Hemoflow™

GUDID 10840861100061

F80A Hemoflow Dialyzer / High Flux / Polysulfone / 1.8 m2 / ETO / Multiple Use / 110 mL

Fresenius Medical Care Holdings, Inc.

Hollow-fibre haemodialysis dialyser, reusable

• Primary Device ID: 10840861100061
• NIH Device Record Key: 122cf55f-e3df-4ae5-bbbe-1febd4a26c56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemoflow™
• Version Model Number: 0500154A
• 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: 1.8 Square meter
• Area/Surface Area: 1.8 Square meter
• Area/Surface Area: 1.8 Square meter
• Area/Surface Area: 1.8 Square meter
• Area/Surface Area: 1.8 Square meter
• Area/Surface Area: 1.8 Square meter
• Area/Surface Area: 1.8 Square meter
• Area/Surface Area: 1.8 Square meter
• Area/Surface Area: 1.8 Square meter
• Area/Surface Area: 1.8 Square meter
• Area/Surface Area: 1.8 Square meter
• Area/Surface Area: 1.8 Square meter
• Area/Surface Area: 1.8 Square meter
• Area/Surface Area: 1.8 Square meter
• Area/Surface Area: 1.8 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	00840861100064 [Primary]
GS1	10840861100061 [Package]; Contains: 00840861100064; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970700

FDA Product Code

• MSF: HEMODIALYZER, RE-USE, HIGH FLUX

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

On-Brand Devices [Hemoflow™]

• 10840861100023: F4 Hemoflow Dialyzer / Low Flux / Polysulfone / 0.7 m2 / ETO / Low Volume / Single Use / 42 mL
• 10840861100016: F3 Hemoflow Dialyzer / Low Flux / Polysulfone / 0.4 m2 / ETO / Low Volume / Single Use / 24 mL
• 10840861100061: F80A Hemoflow Dialyzer / High Flux / Polysulfone / 1.8 m2 / ETO / Multiple Use / 110 mL
• 10840861100054: F60A Hemoflow Dialyzer / High Flux / Polysulfone / 1.3 m2 / ETO / Multiple Use / 82 mL
• 10840861100047: F8 Hemoflow Dialyzer / Low Flux / Polysulfone / 1.8 m2 / ETO / Multiple Use / 110 mL
• 10840861100030: F6 Hemoflow Dialyzer / Low Flux / Polysulfone / 1.3 m2 / ETO / Multiple Use / 82 mL