FDA Registration
Active
🇨🇦 Canada
Cardiocap 5
Reg #: 3009617712
·
FEI: 3009617712
·
Expires 2025
Products
16
Proprietary Names
1
Establishment Types
1
Classifications
16
Registration Details
- Registration Name
- CANUTE INTERNATIONAL MEDICAL SERVICES (CANADA) INC
- Registration Number
- 3009617712
- FEI Number
- 3009617712
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1193 North Service Road West, Unit C2
- City
- Oakville Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K992323
Owner / Operator
- Firm Name
- Canute International Medical Services (Canada) Inc
- Operator Number
- 10041412
- Address
- 1193 North Service Road West, Unit C2
- City
- Oakville
- State
- Ontario
- Postal Code
- L6M 2V8
- Country
- CA
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177 ext. 322
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2013-12-19 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2013-12-19 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2013-12-19 |
| Stimulator, Nerve, Peripheral, Electric | KOI | Class 2 | Anesthesiology | No | 2013-12-19 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2013-12-19 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2013-12-19 |
| Analyzer, Gas, Nitrogen, Gaseous-Phase | CCI | Class 2 | Anesthesiology | No | 2013-12-19 |
| System, Dialysate Delivery, Single Pass | FIL | Class 2 | Gastroenterology, Urology | No | 2013-12-19 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2013-12-19 |
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2013-12-19 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2013-12-19 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2013-12-19 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2013-12-19 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2013-12-19 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2013-12-19 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2013-12-19 |
Proprietary Names
Cardiocap 5
Establishment Types
Export Device to the United States But Perform No Other Operation on Device