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510(k) Data Aggregation

    K Number
    K121145
    Device Name
    RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME
    Manufacturer
    RENU MEDICAL, INC.
    Date Cleared
    2012-06-12

    (57 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    RENU MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReNu Medical Reprocessed Aircast VenaFlow calf, thigh and foot DVT garments are to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to prevent deep vien thrombosis and resulting pulmonary embolism.
    Device Description
    The ReNu Medical Reprocessed Aircast VenaFlow calf, thigh and foot DVT garments. (All sizes)
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    K Number
    K111773
    Device Name
    RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE
    Manufacturer
    RENU MEDICAL, INC.
    Date Cleared
    2011-11-16

    (146 days)

    Product Code
    NLF
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    RENU MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OxiMax Adult: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients > 30 kg. OxiMax Pediatric: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients 10 - 50 kg. OxiMax Infant: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients between 3 kg and 20 kg. OxiMax Neonate: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients foot if < 3 kg, or finger if > 40 kg.
    Device Description
    The ReNy Medical Reprocessed OxiMax Sensors are accessory devices to an oximeter monitoring system. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information. The sensor contains three optical components; two light emitting diodes (LEDs) serve as light sources and one photodiode acting as a light detector LED and sensor are contained in a laminated envelope provided with an adhesive bandage for attachment a patient. A sensor package is attached to a cable terminated in a multi-pin connector that plugs into the oximeter.
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    K Number
    K093658
    Device Name
    RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS
    Manufacturer
    RENU MEDICAL, INC.
    Date Cleared
    2010-01-14

    (50 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    RENU MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReNu Medical Reprocessed Vaso Press CTC calf, thigh and foot DVT garments are to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to prevent deep vein thrombosis and resulting pulmonary embolism.
    Device Description
    The ReNu Medical Reprocessed Vaso Press CTC calf, thigh and foot DVT garments. (All sizes)
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    K Number
    K081927
    Device Name
    RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO
    Manufacturer
    RENU MEDICAL, INC.
    Date Cleared
    2009-02-06

    (214 days)

    Product Code
    NLF
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    RENU MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReNu Medical Reprocessed Oximetry Sensors are intended as single patient use O2 transducer/accessory sensors for use in conjunction with the Masimo™ Oximeter system. The LNCS Adult is used for patients >30 kg. The LNCS Pediatric is used for patients 10-50 kg. The LNCS Infant is used for patients 3-20 kg. The LNCS Neo is used for neonates <3 kg or adults >40 kg. All sensors are used for non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate.
    Device Description
    The ReNu Medical Reprocessed Masimo™ LNCS probes are accessory devices to an oximeter monitoring system. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information. The sensor contains three optical components; two light emitting diodes (LEDs) serve as light sources and one photodiode acting as a light detector LED and sensor are contained in a laminated envelope provided with an adhesive bandage for attachment a patient. A sensor package is attached to a cable terminated in a multi-pin connector that plugs into the oximeter.
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    K Number
    K072194
    Device Name
    RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25
    Manufacturer
    RENU MEDICAL, INC.
    Date Cleared
    2007-11-29

    (114 days)

    Product Code
    NLF
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    RENU MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    D-25 continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients > 30 kg. N-25: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients foot if < 3 kg, or finger if > 40 kg.
    Device Description
    The ReNu Medical Reprocessed Nellcor™ D-25 Oximetry Sensor and Reprocessed Nellcor™ N-25 Oximetry Sensor are accessory devices to an oximeter monitoring system. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information. The sensor contains three optical components; two light emitting diodes (LEDs) serve as light sources and one photodiode acting as a light detector LED and sensor are contained in a laminated envelope provided with an adhesive bandage for attachment a patient. A sensor package is attached to a cable terminated in a multi-pin connector that plugs into the oximeter.
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    K Number
    K063661
    Device Name
    RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20
    Manufacturer
    RENU MEDICAL, INC.
    Date Cleared
    2007-05-25

    (168 days)

    Product Code
    NLF
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    RENU MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    D-20 continuous non-invasive arterial oxygen saturation and pulse rate monitoring of for patients between 10 and 50 kg I-20: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of for patients between 3 and 20 kg
    Device Description
    The ReNu Medical Reprocessed Nellcor™ D-20 Oxysensor® II and Reprocessed Nellcor™ I-20 Oxysensor II are accessory devices to an oximeter monitoring system. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information. The sensor contains three optical components; two light emitting diodes (LEDs) serve as light sources and one photodiode acting as a light detector LED and sensor are contained in a laminated envelope provided with an adhesive bandage for attachment a patient. A sensor package is attached to a cable terminated in a multi-pin connector that plugs into the oximeter.
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    K Number
    K051227
    Device Name
    RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1
    Manufacturer
    RENU MEDICAL, INC.
    Date Cleared
    2006-04-07

    (330 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    RENU MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReNu Medical Reprocessed ALP®1 is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to: - Prevent deep vein thrombosis and resulting pulmonary embolism. - Intra-operative compression therapy.
    Device Description
    The ReNu Medical Reprocessed (up to 18" calf circumference)
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    K Number
    K031559
    Device Name
    RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES
    Manufacturer
    RENU MEDICAL, INC.
    Date Cleared
    2003-11-12

    (177 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    RENU MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hygia West Reprocessed Compression Garments operate in the identical manner as the predicate devices. They are designed for the prevention of deep vein thrombosis (DVT) as well as the treatment of edema secondary to venous insulficiency. The devices are used in both the home and institutional settings. The Hygia West Reprocessed Huntleigh DVT Sleeve is to be used by patients in both the home and institutional settings used as a non-invasive therapeutic method to: - Prevent deep vein thrombosis and resulting pulmonary embolism . - Intra-operative compression therapy
    Device Description
    The Llygia West Reprocessed Compression Garments are intermittent compressible limb devices that are placed around cither the patient's foot (with the compression chamber placed under the plantar arch), calf (gastrocnemius muscle), thigh, or a combination there of. The garments are constructed from materials that are common to the medical device industry. Depending on the type of device, the method of fastening to the patient may vary from a hook and loop closure system to a uni-body style that is slipped over the limb. In foot compression devices, as the garment compresses the plantar plexus, the veins collapse longitudinally; this action causes an increase in the venous pressure thus eiceting the blood upward. After compression, the devices deflate allowing the veins to refill bringing oxygenared blood to the lower limbs. In devices used on the calf or thigh the compression to the area causes the blood to be ejected upwards to the heart, as the compression relaxes the valves in the veins close allowing them to refill. This cyclical method removes deoxygenated or stale blood from the region allowing fresh blood to be received. On all devices the controller predetermines the inflation and deflation sequence. The operational characteristics such as the pressure of compression, hold time, and inflation time are determined by the controller. It is the responsibility of the end user to ensure that the device is connected to an approved controller and to ensure that the controller settings are accurate. Hygia West does not repair, refurhish, or reprocess the controlling unit. Hygia West guarantees 100% of our devices ONLY if it has heen connected to an approved, functional, and correctly adjusted controller.
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