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Accuryn Temperature Cable Adapter
EUDAMEDFDA UDIClass I (EU MDR)
Ref FGN-06-102306
Identity
- Trade Name
- Accuryn Temperature Cable Adapter EUDAMEDFDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Accuryn Temperature Cable Adapter EUDAMEDA reusable short cable adapter that adapts Foleys with 3.5mm round connectors to the Reusable Accuryn Temperature Cable. The Accuryn Temperature Cable Adapter is an accessory of the Accuryn Monitoring System. FDA UDI
- Model / Reference
- FGN-06-102306 EUDAMEDFDA UDI
- Description
- A reusable short cable adapter that adapts Foleys with 3.5mm round connectors to the Reusable Accuryn Temperature Cable. The Accuryn Temperature Cable Adapter is an accessory of the Accuryn Monitoring System. FDA UDI
Identifiers
- Catalog Number
- FGN-06-102306 FDA UDI
- Primary DI / UDI-DI
- 00850019755206 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850019755TempCable95 EUDAMED
- Direct Marketing DI
- 00850019755206 EUDAMED
- FDA Product Code
- PHU FDA UDIEXY FDA UDI
- EMDN Code
- U99 DEVICES FOR UROGENITAL SYSTEM - OTHER EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDU FDA UDI
- Regulation Number
- 876.1800 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Accuryn Temperature Cable Adapter by Potrero Medical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850019755TempCable95 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 277e3cf3-25e2-467f-a9df-cd0b31a7b0ef 61 fields · synced Jun 17, 2026
- FDA UDI 22960468-026a-4504-a401-f4ad7a34fbc0 35 fields · synced May 30, 2026