5008X

GUDID 00840861102860

5008X Standard

Fresenius Medical Care AG

Haemodialysis system, institutional

• Primary Device ID: 00840861102860
• NIH Device Record Key: 0a9cb105-9eff-416e-be86-3aa0fa68bc38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 5008X
• Version Model Number: M204411
• Company DUNS: 324661834
• Company Name: Fresenius Medical Care AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx
• Phone: 1 (800) 227-2572
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861102860 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243505

FDA Product Code

• KDI: Dialyzer, High Permeability With Or Without Sealed Dialysate System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-11
• Device Publish Date: 2025-08-01

On-Brand Devices [5008X]

• 00840861102884: 5008X + CDX
• 00840861102877: 5008X + CLiC
• 00840861102860: 5008X Standard