BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    ORIDION MEDICAL 1987 LTD.

    Reg #: 8044004 · FEI: 3001227743 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    64
    Establishment Types
    2
    Classifications
    12

    Registration Details

    Registration Name
    ORIDION MEDICAL 1987 LTD.
    Registration Number
    8044004
    FEI Number
    3001227743
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7 HAMARPE ST. P.O. BOX 45025
    City
    JERUSALEM
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K013845

    Owner / Operator

    Firm Name
    Covidien llc
    Operator Number
    1282497
    Address
    15 HAMPSHIRE STREET, --
    City
    Mansfield
    State
    MA
    Postal Code
    02048
    Country
    US

    US Agent

    Business Name
    Covidien
    Contact Name
    Kae Miller
    Address
    200 Medtronic Dr
    City
    Lafayette
    State
    CO
    ZIP
    80026
    Country
    US
    Email
    [email protected]
    Phone
    303 4081427

    Products

    Device Name Product Code
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Index-Generating Electroencephalograph Software OLW
    Burst Suppression Detection Software For Electroencephalograph ORT
    Reduced- Montage Standard Electroencephalograph OMC
    Electrode, Cutaneous GXY
    Ventilatory Effort Recorder MNR
    Oximeter DQA
    Connector, Airway (Extension) BZA
    Strap, Head, Gas Mask BTK
    Drain, Tee (Water Trap) BYH
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI

    Proprietary Names

    MAC-Line O2/CO2 Oral Nasal Cannula Sample Line MAC-Line Oral Nasal Cannula Sample Line Carinal VitaLine Set CARESCAPE CO2 Microstream parameter BIS™ Advance Monitoring System Microstream Advance Pediatric Oral- Nasal, with O2 tubing, short-term Microstream Advance Adult Bite Block, short-term Microstream Advance Pediatric Oral- Nasal, short-term Microstream Advance Pediatric Nasal, with O2 tubing, short-term Microstream Advance Adult Nasal, with O2 tubing, 4m, short-term MIcrostream Luer Adult Nasal, with O2 tubing, short-term Microstream Advance Pediatric Nasal, short-term Microstream Advance Adult Nasal, short-term MIcrostream Luer Pediatric Oral-Nasal, with O2, short-term Microstream Luer Adult Oral-Nasal Sampling Line Microstream Advance Adult Oral Nasal CO2 Filter Line with O2 Tubing, extended duration Microstream Advance Pediatric Oral-Nasal FilterLine with O2 Tubing MIcrostream Luer Pediatric Nasal, with O2 tubing, short-term Microstream Advance Adult Oral-Nasal, with O2 connector, 4m, short-term Microstream Advance Adult Oral-Nasal FilterLine with O2 tubing Microstream Advance Neonatal-Infant Nasal FilterLIne with O2 Tubing MIcrostream Luer Adult Oral-Nasal, with O2 tubing, short-term Microstream Advance Pediatric Oral-Nasal, 4m, with O2 tubing, short-term Microstream Advance Adult Oral Nasal CO2 Filter Line with O2 Tubing, 4M, extended duration Microstream Advance Adult Bite Block, with O2 tubing, 4M, short-term Microstream Advance Adult Oral-Nasal, with O2 connector Microstream Luer Adult Bite Block, with O2 tubing, 4M, short-term Microstream Advance Adult Oral-Nasal, 4m, with O2 tubing, short-term Microstream Luer Adult Bite Block, with O2 tubing, short-term Microstream Advance Adult Bite Block, with O2 tubing, short-term Microstream Advance Adult Nasal, with O2 Tubing, short term Microstream Advance Adult Oral-Nasal, with O2 tubing, short-term MAC-Line O2/CO2 Nasal Cannula Sample Line Microstream Oral Nasal Cannula FilterLine BIS Sensor Simulator Capnostream20p FilterLine H (FilterLine ICU) Microstream Filterline Nasal Cannula MAC-Line CO2 Nasal Cannula Sample Line PM35MN02-RR PM35MN01-RR PM35MN05-RR Capnostream35 Portable Respiratory Monitor Microstream O2/CO2 Oral Nasal Filterline O2/CO2 Nasal FilterLine Vista, BISx, BISx4 Airway adapter Microstream Luer Adult-Pediatric Intubated Sampling Line Microstream Luer, short-term Microstream Advance Adult-Pediatric, Intubated, 4m, Long term Microstream Advance Intubated, short-term Microstream Advance Adult-Pediatric Intubated FilterLine Microstream Advance Adult-Pediatric Intubated, High-humidity Microstream Advance Adult-Pediatric Intubated, short-term Advance Adult-Pediatric Intubated, 4M, short-term Microstream CO2 NanoPod Microstream™ Nihon Kohden CO2 NanoPod Hook and Loop Strap Watertrap breathing circuit Male to male adapter Y PIECE) Smart CapnoLine Guardian FilterLine (FilterLine OR/EMS)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device