BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Impilo Phoenix

    Reg #: 3031789039 · FEI: 3031789039 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    9

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    Registration Details

    Registration Name
    Impilo Phoenix
    Registration Number
    3031789039
    FEI Number
    3031789039
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2675 W Buckeye Rd, Suite 200 Phoenix
    City
    Phoenix
    State
    AZ
    ZIP
    85009
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221131

    Owner / Operator

    Firm Name
    Impilo Health
    Operator Number
    10086162
    Address
    2275 Bridge Street
    City
    Philadelphia
    State
    PA
    Postal Code
    19137
    Country
    US

    Products

    Device Name Product Code
    Pack, Hot Or Cold, Disposable IMD
    System, Test, Blood Glucose, Over The Counter NBW
    Blood Specimen Collection Convenience Kit (Excludes Hiv) PQD
    Gauze / Sponge,Nonresorbable For External Use NAB
    Tape And Bandage, Adhesive KGX
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Fiber, Medical, Absorbent FRL

    Proprietary Names

    Instant Hot Pack Mio Blood Glucose Monitoring System Impilo Collection Kit - 1140 McKesson Gauze Sponge 2X2 [1ct] Fingertip Bandage TASSO Blood Lancing Device Transtek TeleRPM BPM Gen-2 Guangdong Transtek Medical Electronics Co MICROTAINER BRAND TUBE WITH EDTA TRANSTEK BLOOD PRESSURE MONITOR Absorbent Sheet 50 mL 3x4

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)