BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BRAEMAR MANUFACTURING, LLC

    Reg #: 2133409 · FEI: 1000520785 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    70
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    BRAEMAR MANUFACTURING, LLC
    Registration Number
    2133409
    FEI Number
    1000520785
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1285 Corporate Center Dr Ste 150
    City
    EAGAN
    State
    MN
    ZIP
    55121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K153473

    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
    Cable, Electrode IKD
    Electrode, Electrocardiograph DRX
    Detector And Alarm, Arrhythmia DSI
    Recorder, Magnetic Tape, Medical DSH

    Proprietary Names

    M1532A ECG Cable M1672A ECG Cable EEG Leadset - 989803180531 M1976A ECG Cable M1663A ECG Trunk Cable EEG Leadset - 989803180561 M1680A ECG Cable M1979A ECG Cable M1602A ECG Cable M1626A ECG Cable M1669A ECG Trunk Cable M1665A ECG Trunk Cable M1681A ECG Cable M1673A ECG Cable M1968A ECG Cable M1644A ECG Cable M1675A ECG Cable M1624A ECG Cable M1949A ECG Trunk Cable M1671A ECG Cable M1674A ECG Cable M1978A ECG Cable M1645A ECG Cable M1973A ECG Cable EEG Leadset - 989803180521 M1667A ECG Trunk Cable M1974A ECG Cable M1971A ECG Cable M1678A ECG Cable M2268A EEG Trunk Cable M1934A EEG Leadset CBL 5 Lead, Snap, Shld, AAMI, Chest, Rgd - 989803176171 M1668A ECG Trunk Cable EEG Leadset - 989803180541 CBL 5 Lead, Snap, Shld, AAMI, Limb, Rgd - 989803176161 M1533A ECG Cable CBL 5 Lead, Snap, Shld, IEC, Limb, Rgd - 989803176181 989803157501, DigiTrak XT Patient Cable, Long 989803157481, DigiTrak XT Patient Cable, short 989803157491, DigiTrak XT Patient Cable, Medium BTP-1000L-2-Lead Wire Adapter Flex Adapter BTP-1000A-Hybrid Patch Lead Wire Adapter OMNI-TRAK 3000 SERIES Nissha Adult Electrode Quadtrode CV MRI ECG Electrode Pad - 989803179041 40494E, Limb Clamp Electrode QUADTRODE MRI ECG PAD,25/BOX - 989803179031 Neonatal Quadtrode MRI ECG Electrode Pad - 989803179051 ePatch ECG Electrode Patch ECG Electrode MCOT Patch Patch electrode ePatch electrode 2-CH Patch Universal Patch BTP-1000P (Patch) Patch Philips ECG Comfort Patch Gel, ECG/EEG, Skin Prep, Tube, 3-Pack BTP-1000M (Monitor) ECG Recorder MCOT Braemar Telemetry Patch System BTPS-1000 Braemar Telemetry Patch System BTPS-1000 BTP-1000S (Sensor) ePatch ePatch ECG Recorder

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device