FDA Registration
Active
🇨🇦 Canada
Cannula Nasal/Oral CO2 ADU 704-0017-00
Reg #: 3000126629
·
FEI: 3000126629
·
Expires 2025
Products
3
Proprietary Names
14
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Philips Electronics Ltd
- Registration Number
- 3000126629
- FEI Number
- 3000126629
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1875 Buckhorn Gate, 5th Floor
- City
- Mississauga Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K031124
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 1217116
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
US Agent
- Business Name
- Philips
- Contact Name
- Shaylee Masilunas
- Address
- 6501 Living Place
- City
- Pittsburgh
- State
- PA
- ZIP
- 15206
- Country
- US
- [email protected]
- Phone
- 724 8162019
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2020-09-22 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2020-09-22 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2020-09-22 |
Proprietary Names
Cannula Nasal/Oral CO2 ADU 704-0017-00
CannulaNasal/Oral CO2/O2 ADU 704-0020-00
Cannula Nasal CO2 Adult 7040010-00
Cannula Nasal CO2/O2 INF 704-0015-00
AIRWAY, DEHUM TBG, ADU PED, SLM LOFLO 10
CannulaNasal/Oral CO2/O2 PED 704-0022-00
Airway Adapter Kit PED/INF 704-0024-00
Cannula Nasal CO2/O2 PED 704-0016-00
Cannula Nasal CO2/O2 ADU 704-0014-00
Sample Line Male Luer Nafion 704-0028-00
AirwayAdapter PED/INF Nafion 704-0026-00
Cannula Nasal CO2 PED 704-0012-00
Airway, ADU-PED, SLM LoFlo, 10
Sample Line Male Luer 704-0027-00
Establishment Types
Export Device to the United States But Perform No Other Operation on Device