Identity
- Trade Name
- CATHETER PERITONEAL ANTI-REFLUX EUDAMEDSophysa FDA UDI
- Generic Name
- Peritoneal/atrial cerebrospinal fluid catheter FDA UDI
- Device Name
- Antireflux peritoneal catheter EUDAMEDANTI-REFLUX PERITONEAL CATHETER FDA UDI
- Model / Reference
- B905S-20 EUDAMEDFDA UDI
- Description
- ANTI-REFLUX PERITONEAL CATHETER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760124130034 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760124130034 EUDAMED
- 510(k) Number
- K013488 FDA UDI
- FDA Product Code
- JXG FDA UDI
- EMDN Code
- N01038099 INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Peritoneal/atrial cerebrospinal fluid catheter FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5550 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Peritoneal/atrial cerebrospinal fluid catheter
Sophysa by Sophysa SA — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Peritoneal/atrial cerebrospinal fluid catheter.
- Integra® — Integra Lifesciences Corp. · Class II
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- Natus® — Natus Medical Incorporated · Class II
- CODMAN® — Integra LifeSciences Production Corporation · Class II
- CODMAN® ACCU-FLO® — Integra LifeSciences Production Corporation · Class II
- Natus® — Natus Medical Incorporated · Class II
Cleared under the same submission
K013488 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sophysa SA
Sources (2)
- FDA UDI c8cf3a71-1521-437b-96e6-da1b18dd23eb 34 fields · synced Jun 18, 2026
- EUDAMED d7f441b2-e849-4df4-8a47-38784f9ceded 61 fields · synced Jun 18, 2026