Identity
- Trade Name
- TubingCRF EUDAMEDFDA UDI
- Generic Name
- Cooling utility supply system FDA UDI
- Device Name
- CRF-TUBE EUDAMEDCRF-TUBE-B EUDAMEDCRF Tubing Set FDA UDI
- Model / Reference
- CRF-TUBE EUDAMEDFDA UDICRF-TUBE-B EUDAMED
- Description
- CRF Tubing Set FDA UDI
Identifiers
- Catalog Number
- CRF-TUBE FDA UDI
- Primary DI / UDI-DI
- 00811746030394 EUDAMEDFDA UDI10811746030391 EUDAMED
- Basic UDI-DI
- B-00811746030394 EUDAMEDB-10811746030391 EUDAMED
- 510(k) Number
- K192715 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
- GMDN Term
- Cooling utility supply system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Foot-switch, electrical
TubingCRF by Cambridge Interventional LLC — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-00811746030394 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Cambridge Interventional LLC
- EUDAMED SRN
- US-MF-000021911
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 6745d62f-6be7-4ff6-a428-aa524d8a2552 61 fields · synced Aug 1, 2026
- EUDAMED cac6f237-f99d-484b-a1d7-3a3c5bdfb1f8 61 fields · synced May 19, 2026
- FDA UDI e8d95d0c-dd93-4d5b-ae8c-42aa91cd6d7e 36 fields · synced May 30, 2026