BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Global Life Sciences Solutions USA LLC

    Reg #: 3012821221 · FEI: 3012821221 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    21
    Establishment Types
    2
    Classifications
    9

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    Registration Details

    Registration Name
    Global Life Sciences Solutions USA LLC
    Registration Number
    3012821221
    FEI Number
    3012821221
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    100 Results Way
    City
    Marlborough
    State
    MA
    ZIP
    01752
    Country
    US

    Regulatory Submissions

    510(k) Number
    K992361

    Owner / Operator

    Firm Name
    Global Life Sciences Solutions USA LLC
    Operator Number
    1831947
    Address
    25 Harbor Park Drive
    City
    Port Washington
    State
    NY
    Postal Code
    11050
    Country
    US

    Products

    Device Name Product Code
    Apparatus, Exhaust, Surgical FYD
    System, Water Purification, General Medical Use NHV
    Spirometer, Diagnostic BZG
    Container, Empty, For Collection & Processing Of Blood & Blood Components KSR
    Syringe, Piston FMF
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Filter, Infusion Line FPB
    Filter, Bacterial, Breathing-Circuit CAH
    Cord Blood Processing System And Storage Container OAO

    Proprietary Names

    LaparoShield Laparoscopic Smoke Filter; LaparoShield Plus Laparoscopic Smoke Filter Pall-Aquasafe Water Filter Pall QPoint™ Disposable Water Filter; Pall QPoint™ Water Filter Capsule Pro-Tec Pulmonary Function Filter Medtronic ATBAG1000; Medtronic ATBAG300; Medtronic ATBAG600 Pall Syringe Filter; PharmAssure Syringe Filter Thermogenesis Transfer/Freezing Bag Set; Transfer/Freezing Bag Set oxygenator gas line filter Gardian 25mm Syringe Filter Freezing Bag; Thermogenesis Freezing Bag Total Nutrient Admixture Filter TNA; Total Nutrient Admixture Filter TNA1 Oxygenator Gas Line Filter SUPOR; SUPOR AEF PharmAssure Vent Filter; Transducer Protector; 25 mm Vent Filter Pall Posidyne ELD; Pall Posidyne ELD 0.2 micron Intravenous Filter; Posidyne NEO Filter Set Conserve Small Volume HME Filter; Ultipor 100 Breathing System Filter; Ultipor 100 Breathing System Filter with CO2 Moni Anesthesia Breathing Circuit - Adult Kit 40 Coax; Anesthesia Breathing Circuit - Adult Kit 60 Coax; Anesthesia Breathing Briostor Transfer/Freezing Bag Set Pall Corp Ultipor U55 Breathing Circuit Bacterial Filter and HME Pall Corp Ultipor U55 Breathing Circuit Bacterial Filter and Heat and Moisture Cell Wash/Infusion Bag; Thermogenesis Cell Wash/Infusion Bag

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198