BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    SIMPLIVIA HEALTHCARE LTD.

    Reg #: 9611423 · FEI: 3002807615 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SIMPLIVIA HEALTHCARE LTD.
    Registration Number
    9611423
    FEI Number
    3002807615
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    NORTH IND. ZONE P.O.BOX 888
    City
    KIRYAT SHMONA Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K231286

    Owner / Operator

    Firm Name
    SIMPLIVIA HEALTHCARE LTD.
    Operator Number
    9001925
    Address
    North Ind. Zone, (Simplivia plant), North Ind. Zone P.O.Box 888
    City
    Kiryat Shmona
    State
    IL-NOTA
    Postal Code
    1101801
    Country
    IL
    Correspondent
    Anat - Coyle

    US Agent

    Business Name
    DONAWA CONSULTING LLC
    Contact Name
    Stephen H. Lieberman
    Address
    4545 N. Ocean Blvd., Unit 11A,
    City
    Boca Raton
    State
    FL
    ZIP
    33431
    Country
    US
    Email
    [email protected]
    Phone
    561 3020777

    Products

    Device Name Product Code
    Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System ONB
    Set, Administration, Intravascular FPA

    Proprietary Names

    OnGuard2 Catheter Adaptor OnGuard2 Secondary IV set OnGuard Closed Adaptor SP OnGuard2 Closed Y Inline Set OnGuard2 Bag Adaptor CP OnGuard®2 Luer Lock Adaptor Chemfort Sterile Caps for Syringe OnGuard®2 20mm Vial Adaptor and 13mm Convertor II OnGuard®2 Bag Adaptor SP II OnGuard®2 Bag Adaptor SP Chemfort 20mm Vial Adaptor II and 13mm convertor OnGuard®2 Syringe Adaptor OnGuard®2 Syringe Adaptor Lock II OnGuard®2 28mm Vial Adaptor OnGuard®2 20mm Vial Adaptor SL and 13mm Convertor OnGuard Spike Port Adaptor OnGuard®2 Female Luer Lock Adaptor OnGuard2 Bag Adaptor LL with ULTRASITE OnGuard2 Bag Adaptor LL OnGuard2 IV Secondary Safety Onguard2 Bag Adaptor SPT OnGuard2 IV Secondary Safety Set with ULTRASITE OnGuard2 Bag Adaptor SP with ULTRASITE

    Establishment Types

    Manufacture Medical Device