BEUDAMED
    FDA Registration Active 🇺🇸 United States

    COAGUSENSE INC

    Reg #: 3007507465 · FEI: 3007507465 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    33
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    COAGUSENSE INC
    Registration Number
    3007507465
    FEI Number
    3007507465
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    48377 Fremont Blvd Ste 113
    City
    Fremont
    State
    CA
    ZIP
    94538
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183255

    Owner / Operator

    Firm Name
    Coagusense Inc
    Operator Number
    10029003
    Address
    48377 Fremont Blvd., ste 113
    City
    Fremont
    State
    CA
    Postal Code
    94538
    Country
    US
    Correspondent
    Mike Acosta

    Products

    Device Name Product Code
    Test, Time, Prothrombin GJS
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    System, Multipurpose For In Vitro Coagulation Studies JPA

    Proprietary Names

    Coag-Sense PT/INR Professional 5-Box Promo (06F73-05) Coag-Sense PT/INR Monitoring System Patient Self Testing (03P70-03) Coag-Sense Portable Printer Paper, Bag of 5 Rolls (PD-99906) Coag-Sense PT2 Replacement Carrying Case (03P75-01) Coag-Sense Patient Test Strip Kit (03P56-50) Coag-Sense PT2 Power Supply, Switching Wall Adaptor, 5v/20W (03P74-01) Sample Transfer Tubes, Glass Plastic Clad with Plunger (03P52-54, 03P52-55) Assure PT Care Test Strip Kit, 50 Count Coag-Sense PT2 Portable Printer, USB and Bluetooth (03P76-01) Coag-Sense Patient Test Strip Kit 50 Count (03P56-50) Coag-Sense Patient Test Strip Kit 50 Count (03P57-50) Coag-Sense PT2 PT/INR Patient Self-Testing 1-Box Promo (06F73-06) Coag-Sense PT/INR Professional 3-Box (06F73-03) Coag-Sense PT/INR Test Strip Kit, Drop Ship Only (03P56-50DS) Coag-Sense PT/INR Test Strip Kit, Drop Ship Only (03P57-50DS) Coag-Sense Prothrombin Time (PT) /INR Patient Self-Test System (03P70-01) Coag-Sense Control Test Strip Kit - 10 (03P69-10) Coag-Sense PT2 Stylus Pen (03P77-01) Sample Transfer Tubes, Glass Plastic Clad with Plunger (03P52-57, 03P52-55) Tera Barcode Scanner with Charging Cradle (03P78-03) Coag-Sense Prothrombin Time PT/INR Professional System (03P70-02) Coag-Sense Prothrombin Time PT/INR Professional System (04P70-02) Coag-Sense PT2 PT/INR Professional 1-Box Promo (06F73-07) Assure PT Care PT/INR Monitoring System Lancets Auto Single Use, 21Ga, 2.2mm depth, sterile (03P58-04) Coag-Sense PT2 Wireless Barcode Scanner (03P78-01) Coag-Sense PT/INR 6 Test Strip Kit w/ Transfer Tube (03P70-06) Coag-Sense PT2 PT/INR Professional 3-Box Promo (06F74-03) Coag-Sense PT2 PT/INR Professional 1-Box Promo (06F74-01) Coag-Sense PT2 PT/INR Professional 5-Box Promo (06F74-05) CoaguSense Prothrombin Time (PT)/INR Monitoring System Coag-Sense PT/INR Monitoring System Patient Self Testing (Self Care) (03P70-03) Immedia

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device