FX CorAL

GUDID 04039361259624

FX CorAL 600

Fresenius Medical Care AG

Hollow-fibre haemodialysis dialyser, single-use

• Primary Device ID: 04039361259624
• NIH Device Record Key: 03b1afd3-bfec-477a-b054-1a7f9670117b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FX CorAL
• Version Model Number: F00012973
• Company DUNS: 324661834
• Company Name: Fresenius Medical Care AG
• 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: 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: 1.6 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04039361259617 [Primary]
GS1	04039361259624 [Package]; Contains: 04039361259617; 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: 2026-01-12
• Device Publish Date: 2026-01-02

On-Brand Devices [FX CorAL]

• 04039361259945: FX CorAL 120
• 04039361259662: FX CorAL 1000
• 04039361259648: FX CorAL 800
• 04039361259624: FX CorAL 600
• 04039361259600: FX CorAL 100
• 04039361259587: FX CorAL 80
• 04039361259167: FX CorAL 60