BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Respironics Alice, LoFlo, C5 Sidestream Module

    Reg #: 1219324 · FEI: 1219324 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    37
    Establishment Types
    1
    Classifications
    1

    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
    K053174

    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

    Proprietary Names

    Respironics Alice, LoFlo, C5 Sidestream Module Carescape CO2 - LoFlo Respironics LoFlo Sidestream CO2 Module Respironics LoFlo Sidestream CO2 Module for Goldway Respironics LoFlo Sidestream CO2 Module for GE C5 LoFlo Sidestream Module LoFlo Module - RoHS - Private Label LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing PEDIATRIC ORAL/NASAL Sample Line-Female Luer Connector LoFlo CO2 Sampling Cannula PEDIATRIC ORAL/NASAL LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT NASAL LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC NASAL LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT NASAL LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC NASAL LoFlo CO2 Sampling Cannula ADULT ORAL/NASAL LoFlo CO2 Sampling Cannula PEDIATRIC NASAL LoFlo Airway Adapter Kit w/ Dehumidification Tubing Adult/Pediatric LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL Cobranded LoFlo Sampling Line Kit LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC ORAL/NASAL LoFlo CO2 Sampling O2 Delivery Cannula ADULT ORAL/NASAL LoFlo SAMPLING LINE KIT LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT ORAL/NASAL Cobranded LoFlo CO2 Sampling Cannula LoFlo CO2 Sampling Cannula ADULT NASAL LoFlo CO2 Sampling O2 Delivery Cannula ADULT NASAL LoFlo Airway Adapter Kit ADULT/PEDIATRIC LoFlo CO2 Sampling Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL LoFlo Airway Adapter Kit INFANT/NEONATAL LoFlo Airway Adapter Kit w/Dehumidification Tubing INFANT/NEONATAL LoFlo SAMPLING LINE KIT w/Dehumidification Tubing LoFlo CO2 Sampling O2 Delivery Cannula INFANT/NEONATAL NASAL LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT ORAL/NASAL LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC ORAL/NASAL LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing PEDIATRIC NASAL Cobranded LoFlo Sampling Line Kit w/Dehumidification Tubing LoFlo CO2 Sampling Cannula INFANT/NEONATAL NASAL

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility