BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CARESTREAM MEDICAL

    Reg #: 3010396502 · FEI: 3010396502 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    4

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    Registration Details

    Registration Name
    CARESTREAM MEDICAL
    Registration Number
    3010396502
    FEI Number
    3010396502
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1201 Upsala Rd
    City
    Sanford
    State
    FL
    ZIP
    32771
    Country
    US

    Regulatory Submissions

    510(k) Number
    K080039

    Owner / Operator

    Firm Name
    CAREstream Medical LTD
    Operator Number
    10044901
    Address
    443 Palm Crest Lane
    City
    Lake Mary
    State
    FL
    Postal Code
    32746
    Country
    US
    Correspondent
    Scott Petrunick

    Products

    Device Name Product Code
    Apparatus, Gas-Scavenging CBN
    Mixer, Breathing Gases, Anesthesia Inhalation BZR
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Platelet And Plasma Separator For Bone Graft Handling ORG

    Proprietary Names

    Passive waste gas scavenger model 14600 Pro-Nox Pro-Vac Blower Active Waste Gas Scavenger A2M

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device