Hemoflow™

GUDID 04039361001117

F40S Hemoflow Dialyzer / High Flux / Polysulfone / 0.7 m2 / Steam / Single Use / 42 mL

Fresenius Medical Care AG & Co. KGaA

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 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 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: 04039361001117
• NIH Device Record Key: cd00924c-f513-4201-8a85-6c5b44379e00
• Commercial Distribution Discontinuation: 2024-05-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Hemoflow™
• Version Model Number: 0500714S
• Company DUNS: 324661834
• Company Name: Fresenius Medical Care AG & Co. KGaA
• 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
• 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
• Phone: +1(800)323-5188
• Email: xx@xx.xx
• Phone: +1(800)323-5188
• Email: xx@xx.xx

Device Dimensions

• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 Square meter
• Area/Surface Area: 0.7 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
• 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	04039361001100 [Primary]
GS1	04039361001117 [Package]; Contains: 04039361001100; Package: [12 Units]; Discontinued: 2024-05-21; Not in Commercial Distribution

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: 2024-06-12
• Device Publish Date: 2015-10-23

Devices Manufactured by Fresenius Medical Care AG & Co. KGaA

• 04039361001117 - Hemoflow™: 2024-06-12F40S Hemoflow Dialyzer / High Flux / Polysulfone / 0.7 m2 / Steam / Single Use / 42 mL
• 04039361001117 - Hemoflow™: 2024-06-12 F40S Hemoflow Dialyzer / High Flux / Polysulfone / 0.7 m2 / Steam / Single Use / 42 mL
• 04039361001391 - Diasafe: 2020-03-30 FILTER, DIASAFE PLUS