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510(k) Data Aggregation

    K Number
    K200893
    Device Name
    ProntoPump Sterile Tube Set
    Manufacturer
    Date Cleared
    2021-05-04

    (396 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    IPAX, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Pronto Pump Tube Set is a part of the Pronto Pump System. This tube set provides peristaltic pump driven fluid transfer that facilities repeatable drug dosage distribution in healthcare environments. The Pronto Pump Tube set provides the fluid path way and pumping mechanism for the pump system. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile. The ProntoPump Sterile Tube Sets are fluid transfer tube sets used in conjunction with the ProntoPump pharmacy pump in hospital and compounding pharmacies to provide a pathway through which fluid is transferred from one source container into another suitable container. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile.
    Device Description
    The ProntoPump sterile tube set is a single channel tube set for use with the ProntoPump pharmacy pump. It consists of clear plastic tubing connected to a silicone tube that functions as a peristaltic pumping chamber. Peristaltic pumps function by a roller compressing the pump tubing and rolling along the length of the tube, squeezing the fluid inside the tube from one end to the other. It has a plastic cassette that holds the pumping chamber in place for insertion into the ProntoPump, which provides the rollers that the force the fluid to move. The proximal and distal ends of the PVC tubing have connectors for various devices and containers. Using the ProntoPump, the tube set is used to deliver specified volumes of liquid into a final dosing container in hospital pharmacies or compounding pharmacies. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile. The cassette is non-fluid-contact and helps hold the tubing in place for loading. It has a machine-readable barcode that can be read by the pharmacy pump. The barcode includes information about the particular tube set item number, lot number, and expiration date, which is used by pharmacy pump to facilitate set up of the tubing. The tube set is intended to be used by trained healthcare personnel, and is not intended to be used for direct patient contact. Tube sets are packaged individually in a peel pouch and sterilized by radiation.
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    K Number
    K971242
    Device Name
    BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)
    Manufacturer
    Date Cleared
    1997-12-17

    (259 days)

    Product Code
    Regulation Number
    886.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    IPAX, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Blink Gold Eyelid Weight Implants, surgically implanted in the upper eyelid, work by gravity to restore a functional blink mechanism in the patient with lagophthalmos resulting from temporary or permanent facial paralysis, specifically the orbicularis oculi muscle. This paralysis may be the result of Bell's palsy or from surgical trauma to the facial nerve. Functional defects which may be corrected or avoided with the use of Blink Gold Eyelid Weight Implants include inadequate eyelid closure, corneal exposure, serious keratopathy such as ocular irritation, keratitis, corneal abrasion or ulceration. These conditions may result in decreased vision. The patient with lagophthalmos is unable to close the eyelid completely because of partial or complete paralysis to the facial nerve. This paralysis may be the result of Bell's palsy or from surgical trauma to the facial nerve. The condition of paralysis can be either permanent or transient.
    Device Description
    The Blink Gold Eyelid Weight Implants are spherically radiused strips of pure gold, constructed in twelve sizes ranging from 0.6 grams to 2.8 grams in 0.2 gram increments. All product specifications are identical to the predicate device, the Series 3000 Gold Eyelid Implant, produced by MedDev Corporation. The Blink Gold Eyelid Weight Implant is implanted into the evelid following the surgical technique described in the product brochure. This technique is identical to the technique used to implant the predicate device, the Series 3000 Gold Eyelid Implant. Blink Gold Eyelid Weight Implants are constructed of pure gold (99.99%). The weights are designed in a rectangular shape with a spherical radius of curvature of 12.7 mm which conforms to the shape of the eye. All edges are smoothly rounded. Suture holes are placed in the implant to allow the surgeon to secure it to the tarsus or orbital septum. In the engineering specifications, dimensions are stated in the plano view. In the product literature, dimensions are stated in the radiused view.
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    K Number
    K971245
    Device Name
    BLINK EXTERNAL EYELID WEIGHT
    Manufacturer
    Date Cleared
    1997-06-20

    (78 days)

    Product Code
    Regulation Number
    886.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    IPAX, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Blink External Eyelid Weights, attached to the outer skin of the upper eyelid with an adhesive, work by gravity to restore a functional blink mechanism to the patient who suffers from lagophthalmos resulting from temporary or permanent facial paralysis, specifically the orbicularis oculi muscle. This paralysis may be the result of Bell's palsy or from surgical trauma to the facial nerve. Functional defects which may be corrected or avoided with the use of Blink External Eyelid Weights include inadequate evelid closure, corneal exposure, serious keratopathy such as ocular irritation, keratitis, corneal abrasion or ulceration. These conditions may result in decreased vision.
    Device Description
    The Blink External Evelid Weights are spherically radiused strips of pure tantalum, constructed in twelve sizes ranging from 0.6 grams to 2.8 grams in 0.2 gram increments. The Blink External Weight is attached to the outer skin of the upper eyelid with a double coated adhesive tape strip or with mastisol. Blink External Eyelid Weights are offered in four flesh tone colors: White. Tan. Medium Brown and Dark Brown Only the top surface of the weight is painted. The underneath surface is bare tantalum metal. The physical specifications and materials used in the construction of the Blink External Eyelid Weights are identical to the EyeClose External Eyelid Weights. Blink External Eyelid Weights are produced to the same specifications as the EyeClose External Weights. Blink External Eyelid Weights are constructed of pure tantalum. The weights are designed in a rectangular shape with a spherical radius of curvature of 12.7 mm which conforms to the shape of the eye. All edges are smoothly rounded. The top surface is painted with a Polane 2.8 T Plus polyurethane enamel paint.
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