Top Tray

GUDID 04039361274580

Top Tray

Fresenius Medical Care AG

Haemodialysis system, institutional

• Primary Device ID: 04039361274580
• NIH Device Record Key: 225f3c23-3691-40b2-b01f-634159065933
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Top Tray
• Version Model Number: F50044948
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	04039361274580 [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

Devices Manufactured by Fresenius Medical Care AG

• 00840861102860 - 5008X: 2025-08-11 5008X Standard
• 00840861102877 - 5008X: 2025-08-11 5008X + CLiC
• 00840861102884 - 5008X: 2025-08-11 5008X + CDX
• 04039361207953 - Blood Pressure Cuff: 2025-08-11 BPM cuff, 500 to 700 mm, size XL
• 04039361207960 - Blood Pressure Cuff: 2025-08-11 BPM cuff, 340 to 500 mm, size L
• 04039361208073 - Blood Pressure Cuff: 2025-08-11 BPM cuff, 240 to 340 mm, size M
• 04039361208080 - Blood Pressure Cuff: 2025-08-11 BPM Cuff, 170 to 240 mm, size S
• 04039361274573 - Support plate: 2025-08-11 Support plate