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510(k) Data Aggregation
K Number
K111007Device Name
MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE
Manufacturer
MIDWEST REPROCESSING CENTER LLC
Date Cleared
2011-06-08
(58 days)
Product Code
NMD
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
MIDWEST REPROCESSING CENTER LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Midwest Reprocessing Center (MRC) Reprocessed Cerebral-Somatic Oximetry Sensors are indicated for use when continuous noninvasive trending of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor is required.
Device Description
Midwestern Reprocessing Center (MRC) Reprocessed Cerebral-Somatic Oximetry Sensors (CSS) are optical devices which use dual-wavelength light to determine a patient's current regional oxygen saturation level. Once a sensor has been applied to the patient, a light source in the sensor sends red and near-infrared light through the skin surface and photodiodes measure the reflected light. This signal is sent back to a monitor which calculates the patient's trending oxygenation levels.
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K Number
K101280Device Name
MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE
Manufacturer
MIDWEST REPROCESSING CENTER LLC
Date Cleared
2010-10-07
(154 days)
Product Code
NLF
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
MIDWEST REPROCESSING CENTER LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MRC Reprocessed Pulse Oximeter sensors are used as a noninvasive method to provide continuous SpO2 monitoring and pulse rate monitoring. These devices are intended for prescription use.
Device Description
The Midwestern Reprocessing Center reprocessed pulse oximeter sensors are non-invasive sensors used to provide continuous SpO2 monitoring and pulse rate. The sensors contain a dual wavelength light emitting diode (LED), and an optical photodiode sensor which are housed in a pad which attaches to the patient using adhesive material. The LED emits red and infrared light in alternate pulses, governed by the Oximeter instrument. The photodiode sensor responds to the light and generates a current that is interpreted by the Oximeter instrument. The Oximeter instrument interprets the different amounts of each light type (red and infrared) from the output of the photodiode and interprets the information and displays a reading. The sensor operates without any type of tissue penetration, electrical contact, or heat transfer to the patient. The sensors use optical means to determine the light absorption of functional arterial hemoglobin. The sensor is indicated for use as a non-invasive method to provide continuous SpO2 monitoring and pulse rate.
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K Number
K101330Device Name
MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE
Manufacturer
MIDWEST REPROCESSING CENTER LLC
Date Cleared
2010-08-27
(107 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
MIDWEST REPROCESSING CENTER LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Midwestern Reprocessing Center reprocessed sleeves/foot garments are intended to be used in the same manner as the predicated devices. They are designed to apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis in patients at risk. The devices are intended to be used in both the home and institutional settings on patient populations for which these devices are applicable.
The Midwest Reprocessing Center Reprocessed Aircast Sleeves/Foot Cuffs are used in the treatment of venous leg/foot ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Aircast Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.
The Midwest Reprocessing Center Reprocessed ALP® DVT Sleeve is used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency.
The Midwest Reprocessing Center Reprocessed Kendall SCD Express® Sleeves/Foot Cuffs are used in the treatment of venous leg/foot ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Kendall SCD Express® Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.
The Midwest Reprocessing Center Reprocessed Kendall SCD™ Sleeve is used in the treatment of venous leg/foot ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Kendall SCD™ Sleeve is also a non-invasive therapeutic method for prevention of deep vein thrombosis.
The Midwest Reprocessing Center Reprocessed Novamedix ImPad® is designed to enhance circulation of blood in the venules and arterioles. It is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to: Prevent deep vein thrombosis, Reduce wound healing time, Treat and assist healing of venous leg ulcers, Reduce edema caused by venous insufficiency in the lower extremities.
The Midwest Reprocessing Center Reprocessed Venodyne Sleeves are used in the treatment of venous leg ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Venodyne Sleeves are also a noninvasive therapeutic method for prevention of deep vein thrombosis.
The Midwest Reprocessing Center Reprocessed Venodyne Foot Cuffs are used in the treatment of venous leg/foot ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Venodyne Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.
The Midwest Reprocessing Center Reprocessed CTC VasoPress Compression Sleeves are used as a noninvasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency.
The Midwest Reprocessing Center Reprocessed Nutech® Combo is used as a non-invasive therapeutic method by patients in the home or institutional setting in order to: Prevent deep vein thrombosis, Reduce wound healing time, Treat and assist healing of venous leg ulcers, Reduce edema caused by venous insufficiency in the lower extremities.
The Midwest Reprocessing Center Reprocessed Nutech® Calf Wrap is used as a non-invasive therapeutic method to be used by patients in the home or institutional setting in order to: Prevent deep vein thrombosis, Reduce wound healing time, Treat and assist healing of venous leg ulcers, Reduce edema caused by venous insufficiency in the lower extremities.
The Midwest Reprocessing Center Reprocessed Nutech® Foot Wrap is designed to enhance circulation of blood in the venules and arterioles. It is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to prevent: Deep vein thrombosis, Reduce wound healing time, Treat and assist healing of venous leg ulcers, Reduce edema caused by venous insufficiency in the lower extremities, Decrease compartmental pressures.
The Midwest Reprocessing Center Reprocessed Huntleigh Flowtron® Single Pulse DVT Sleve is used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency.
The Midwest Reprocessing Center Reprocessed Huntleigh Foot Wrap is designed to enhance circulation of blood in the venules and arterioles. It is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to prevent: Deep vein thrombosis, Reduce wound healing time, Treat and assist healing of venous leg ulcers, Reduce edema caused by venous insufficiency in the lower extremities, Decrease compartmental pressures.
Device Description
The Midwestern Reprocessing Center reprocessed sleeves/foot garments are compression devices that, when attached to an approved controller, provide intermittent, sequentially gradient pressure to a patient's leg/foot for the prevention of Deep Vein Thrombosis (DVT). As the sleeves/cuffs compress the legs/feet, veins collapse, forcing the blood to move upward towards the heart. After compression, the sleeves/cuffs deflate which allows the veins to reopen and bring oxygenated blood to the region. The inflation and deflation sequence is predetermined by the product's specific controller. The pressure of compression is determined by the controller.
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K Number
K101702Device Name
MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS
Manufacturer
MIDWEST REPROCESSING CENTER LLC
Date Cleared
2010-08-27
(71 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
MIDWEST REPROCESSING CENTER LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Midwestern Reprocessing Center reprocessed sleeves/foot garments are intended to be used in the same manner as the predicated devices. They are designed to apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis in patients at risk. The devices are intended to be used in both the home and institutional settings on patient populations for which these devices are applicable.
The Midwest Reprocessing Center Reprocessed Venodyne Sleeves are used in the treatment of venous leg ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Venodyne Sleeves are also a non-invasive therapeutic method for prevention of deep vein thrombosis.
The Midwest Reprocessing Center Reprocessed Venodyne Foot Cuffs are used in the treatment of venous leg / foot ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Venodyne Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.
The Midwest Reprocessing Center Reprocessed CTC VasoPress Compression Sleeves are used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat vanous leg ulcers and edema that result from venous insufficiency.
The Midwest Reprocessing Center Reprocessed NuTech® Combo is used as a non-invasive therapeutic method by patients in the home or institutional setting in order to: Prevent deep vein thrombosis, Reduce wound healing time, Treat and assist healing of venous leg ulcers, Reduce edema caused by venous insufficiency in the lower extremities.
The Midwest Reprocessing Center Reprocessed NuTech® Calf Wrap is used as a noninvasive therapeutic method to be used by patients in the home or institutional so thiosi order to: Prevent deep vein thrombosis, Reduce wound healing time, Treat and assist healing of venous leg ulcers, Reduce edema caused by venous insufficiency in the lower extremities.
The Midwest Reprocessing Center Reprocessed NuTech® Foot Wrap is designed to enhance circulation of blood in the venules and arterioles. It to be used by patient's in both the home and institutional settings as a non-invasive therapeutic method to prevent: Deep vein thrombosis, Reduce wound healing time, Treat and assist healing of venous leg ulcers, Reduce edema caused by venous insufficiency in the lower extremities, Decrease compartmental pressures.
The Midwest Reprocessing Center Reprocessed Huntleigh Flowtron® Single Pulse DVT Sleeve is used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency.
The Midwest Reprocessing Center Reprocessed Huntleigh Foot Wrap is designed to enhance circulation of blood in the venules and arterioles. It is to be used by patient's in both the home and institutional settings as a non-invasive therapeutic method to prevent: Deep vein thrombosis, Reduce wound healing time, Treat and assist healing of venous leg ulcers, Reduce edema caused by venous insufficiency in the lower extremities, Decrease compartmental pressures.
Device Description
The Midwestern Reprocessing Center reprocessed sleeves/foot garments are compression devices that, when attached to an approved controller, provide intermittent, sequentially gradient pressure to a patient's leg/foot for the prevention of Deep Vein Thrombosis (DVT). As the sleeves/cuffs compress the legs/feet, veins collapse, forcing the blood to move upward towards the heart. After compression, the sleeves/cuffs deflate which allows the veins to reopen and bring oxygenated blood to the region. The inflation and deflation sequence is predetermined by the product's specific controller. The pressure of compression is determined by the controller.
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