FX CorAL 80 Dialyzer

GUDID 10840861102645

Fresenius Medical Care Holdings, Inc.

Hollow-fibre haemodialysis dialyser, single-use

• Primary Device ID: 10840861102645
• NIH Device Record Key: b48e2a82-878a-4770-8ff1-290b7a608e73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FX CorAL 80 Dialyzer
• Version Model Number: F00009217
• 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: true
• Manufacturing Date: true
• 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

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
• 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
• 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	00840861102648 [Primary]
GS1	10840861102645 [Package]; Contains: 00840861102648; Package: Case [24 Units]; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-12
• Device Publish Date: 2023-10-04

Devices Manufactured by Fresenius Medical Care Holdings, Inc.

• 20840861100549 - Fresenius: 2025-08-07 Transducer Protectors, bulk pack
• 10840861102638 - FX CorAL 60 Dialyzer: 2024-03-04
• 10840861102652 - FX CorAL 100 Dialyzer: 2024-03-04
• 10840861102669 - FX CorAL 120 Dialyzer: 2024-03-04
• 10840861102676 - FX CorAL 600 Dialyzer: 2024-03-04
• 10840861102683 - FX CorAL 800 Dialyzer: 2024-03-04
• 10840861102690 - FX CorAL 1000 Dialyzer: 2024-03-04
• 10840861102409 - CombiSet: 2023-10-27