BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cannula Nasal/Oral CO2 ADU 704-0017-00

    Reg #: 1219324 · FEI: 1219324 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    RESPIRONICS NOVAMETRIX, LLC
    Registration Number
    1219324
    FEI Number
    1219324
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3000 Minuteman Rd.
    City
    Andover
    State
    MA
    ZIP
    01810
    Country
    US

    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

    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

    Develop Specifications But Do Not Manufacture At This Facility