BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Philips North America LLC

    Reg #: 3030677 · FEI: 1000524572 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    67
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    Philips North America LLC
    Registration Number
    3030677
    FEI Number
    1000524572
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    22100 Bothell Everett Hwy
    City
    Bothell
    State
    WA
    ZIP
    98021
    Country
    US

    Regulatory Submissions

    510(k) Number
    K984286
    PMA Number
    P160029

    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
    Automated External Defibrillators (Non-Wearable) MKJ
    Over-The-Counter Automated External Defibrillator NSA
    Dc-Defibrillator, Low-Energy, (Including Paddles) LDD
    Mask, Oxygen, Non-Rebreathing KGB
    Cable, Electrode IKD

    Proprietary Names

    M5071A Adult SMART Pads Cartridge M5070A Primary Battery M5072A Infant/Child SMART Pads Cartridge M5068A HeartStart Home Defibrillator M5066A HeartStart Onsite Defibrillator 05-10100 - Heartstream Pads to Zoll Adapter 989803150031 Pediatric Key 989803149981 and 989803149991 SMART Pads III 989803150161 Primary Battery 989803158211 and 989803158221 DP Pads M4744A Small Switched Internal Paddles, 2.8 cm M4743A Medium Switched Internal Paddles, 4.5 cm M4741A Extra Large Switched Internal Paddles ,7.5 cm M4742A Large Switched Internal Paddles, 6 cm 989803139301 Aviation FRx Battery 989803139261 SMART Pads II 861304 HeartStart FRx Defibrillator 989803139311 Infant/Child Key 68-PCHAT, Fast Respond Kit 989803150111, Fast Response Kit, FR3 Pads Adapter 05-10000 - Heartstream Pads to QUIK-COMBO Adapter [FR2] 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

    Establishment Types

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