Identity
- Trade Name
- Accuryn Monitor EUDAMEDFDA UDI
- Generic Name
- Multi-parameter urinary monitoring system control unit FDA UDI
- Device Name
- Accuryn Monitor EUDAMEDThe Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System with the Accuryn Sensing Urinary Catheter (SmartFoley) - IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The Accuryn Sensing Urinary Catheter is a single use device intended for short term use (less than 30 days). FDA UDI
- Model / Reference
- FGN-06-2687 EUDAMEDFDA UDI
- Description
- The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System with the Accuryn Sensing Urinary Catheter (SmartFoley) - IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The Accuryn Sensing Urinary Catheter is a single use device intended for short term use (less than 30 days). FDA UDI
Identifiers
- Catalog Number
- FGN-06-2687 FDA UDI
- Primary DI / UDI-DI
- 00868475000235 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00868475000235 EUDAMED
- FDA Product Code
- PHU FDA UDIEXY FDA UDIEZL FDA UDI
- EMDN Code
- U0599 URODYNAMICS DEVICES - OTHER EUDAMED
- GMDN Term
- Multi-parameter urinary monitoring system control unit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Regulation Number
- 876.1800 FDA UDI876.5130 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Accuryn Monitor by Potrero Medical, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00868475000235 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Potrero Medical, Inc.
- EUDAMED SRN
- US-MF-000033318
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 21cac240-f1c5-4b3f-9871-10cd512f21d2 61 fields · synced Oct 6, 2026
- FDA UDI 34ac1edd-54d6-4547-b108-8c65aceb4d62 37 fields · synced May 29, 2026