alfapump System

GUDID 07640168020507

alfapump System (catalog number 01485) is composed of the following devices: 01473 - alfapump 01474 - Bladder Catheter 01478 - Tunneling Rod 01472 - Implant Accessories 01475 - Smart Charger 01476 - Docking Station 01991 - Introducer Kit 02155 - Peritoneal Catheter SNCA-5262L

Sequana Medical NV, Ghent, Zweigniederlassung Zürich

Abdominal fluid shunt system

• Primary Device ID: 07640168020507
• NIH Device Record Key: 54618d3f-e06d-4bf8-94eb-c66d2fd92f2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: alfapump System
• Version Model Number: 01485
• Company DUNS: 480401893
• Company Name: Sequana Medical NV, Ghent, Zweigniederlassung Zürich
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07640168020507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P230044

FDA Product Code

• SDQ: Alfapump 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: 2025-08-18
• Device Publish Date: 2025-08-08

Devices Manufactured by Sequana Medical NV, Ghent, Zweigniederlassung Zürich

• 07640168020507 - alfapump System: 2025-08-18alfapump System (catalog number 01485) is composed of the following devices: 01473 - alfapump 01474 - Bladder Catheter 01478 - Tunneling Rod 01472 - Implant Accessories 01475 - Smart Charger 01476 - Docking Station 01991 - Introducer Kit 02155 - Peritoneal Catheter SNCA-5262L
• 07640168020507 - alfapump System: 2025-08-18 alfapump System (catalog number 01485) is composed of the following devices: 01473 - alfapump 01474 - Bladder Catheter 01478 - T
• 07640168020521 - Smart Charger - Single Item Packaging: 2025-08-18
• 07640168020538 - Docking Station - Single Item Packaging: 2025-08-18
• 07640168020545 - Implant Accessories - Single Item Packaging: 2025-08-18
• 07640168020798 - Introducer Kit - Single Item Packaging: 2025-08-18
• 07640168020804 - Peritoneal Catheter SNCA-5262L - Single Item Packaging: 2025-08-18
• 07640168020828 - Tunneling Rod - Single Item Packaging: 2025-08-18
• 07640168020880 - alfapump - Single Item Packaging: 2025-08-18