Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K231719
    Device Name
    Medical Surgical Mask
    Manufacturer
    Azur Medical Company Inc.
    Date Cleared
    2024-03-19

    (280 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Azur Medical Company Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
    Device Description
    The Medical Surgical Mask is single use, flat-pleated masks that are provided in blue. The Medical Surgical Mask is available in two types, which are Level 2 and Level 3 based on ASTM F2100-19. The inner and outer layers of the mask are made of polypropylene non-woven fabric, the middle layer is made of polypropylene meltblown fabric, and the nose clip is made of polypropylene and iron wire. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loops are made of spandex. The ear loops are held in place over the users' mouth and nose by two ear loops welded to the mask. This is a single use, disposable device(s), provided non-sterile.
    Ask a Question
    K Number
    K211210
    Device Name
    Sterile Auto-Disable Syringes with/without Needle for Single Use
    Manufacturer
    Azur Medical Company Inc.
    Date Cleared
    2022-01-27

    (279 days)

    Product Code
    FMF, FMI
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Azur Medical Company Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Auto-Disable syringes with/without needle for single use is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.
    Device Description
    The Sterile Auto-Disable syringes with/without needle for single use is a syringe with or without needle, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The main principle of the syringe is that after the injection is completed, the device automatically locks the plunger to prevent reuse.
    Ask a Question
    K Number
    K211214
    Device Name
    Sterile Hypodermic Needles for Single Use
    Manufacturer
    Azur Medical Company Inc.
    Date Cleared
    2021-10-14

    (174 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Azur Medical Company Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip syringe and injection devices for general purpose fluid injection/aspiration.
    Device Description
    The Sterile Hypodermic Needles for Single Use is composed of a needle hub, protective cover, needle tube and jointing. The Sterile Hypodermic Needles for Single Use is for single use only, It is provided sterile. The sterilization method is EO sterilization and the sterilization assurance level is 10-6.
    Ask a Question
    K Number
    K211211
    Device Name
    Sterile syringes for single use with/without needle
    Manufacturer
    Azur Medical Company Inc.
    Date Cleared
    2021-10-07

    (167 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Azur Medical Company Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile syringes for single use with/without needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
    Device Description
    The Sterile Syringes for Single Use with/without Needle is a three-piece, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.
    Ask a Question

    Page 1 of 1