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510(k) Data Aggregation
K Number
K971543Device Name
LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP
Manufacturer
KAWECO GMBH
Date Cleared
1997-09-18
(143 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
KAWECO GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of this electrically powered (diaphragm-type) suction device is to express milk from the breast.
Device Description
The Luxmatic 12-15 ISC Portable Electric Breast Pump (suction device with a compressor unit) contains a diaphragm-type pump with a vacuum regulator (between 150mm Hg and 220mm Hg) which includes a soft silicone tube and plastic tubing. An accessory kit includes overflow safety bottles, plastic breast shields and a collection cup. The device is battery and line-powered for 12V DC by a transformer or utilizes a 12V battery pack. The device is controlled by an electric sensor with intermittent suction at approximately 30-45 cycles. The overflow bottle contains an optical sensor, with an automatic shut off. The motor stops when liquid is sucked into the overflow. The pump can be used with Single Breast Pump Kit #281100 or Double Breast Pump Kit #281102. Dimensions are 7 X 12 X 7 inches and the weight is 4.5 lbs. Suction is controlled by the pump automatically. It will automatically be released when the adjusted vacuum is reached. An electronic sensor is built-in for automatic motor shut off: If milk flows into the overflow bottle, the motor stops automatically at once and the inside valves from the pump cannot be damaged through the milk. A bacterial filter may be used between the overflow bottle and the pump to prevent cross infection when more than one patient is using the pump. Bacterial filters should be changed regularly.
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