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
Phone
724 8162019

Products

Device Name Product Code
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
Analyzer, Gas, Oxygen, Gaseous-Phase CCL

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