FDA UDI
In Commercial Distribution
🇺🇸 United States
alfapump System
DI: 07640168020507
·
Model: 01485
·
Sequana Medical NV, Ghent, Zweigniederlassung Zürich
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- alfapump System
- Primary DI
- 07640168020507
- Version / Model
- 01485
- Company Name
- Sequana Medical NV, Ghent, Zweigniederlassung Zürich
- Labeler DUNS
- 480401893
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-08
- Public Version
- 3
- Public Version Date
- 2026-02-24
- Public Version Status
- Update
- Public Device Record Key
- 54618d3f-e06d-4bf8-94eb-c66d2fd92f2a
Device Description
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
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| SDQ | Alfapump System | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47551 | Abdominal fluid shunt system | An assembly of implantable devices designed to actively drain ascitic fluid (ascites) from the abdominal cavity into the bladder for urinary voiding. It typically consists of a battery-powered, programmable pump implanted beneath the skin of the abdomen in a surgically-created pocket, and fluid draining catheters [one placed in the cavity (e.g., peritoneal) for fluid collection, and another that connects the pump to the urinary bladder]. The pump is typically charged and programmed transcutaneously using a noninvasive hand-held charger/programmer; some pumps are able to wirelessly transmit performance data to an external device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640168020507 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P230044 | 001 |
| P230044 | 002 |
| P230044 | 003 |