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510(k) Data Aggregation
K Number
K020375Device Name
THE NURTURE III BREAST PUMP
Manufacturer
Date Cleared
2002-05-03
(88 days)
Product Code
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
BAILEY MEDICAL ENGINEERING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nurture III Breast Pump is intended for use by lactating women to express their rrile Nature in Broad for multiple users as long as each of those users has her own collection kit.
Device Description
The Nurture III Breast Pump utilizes a diaphragm type vacuum pump operating on either 115 VAC/60 Hz or 220 VAC/50 Hz. The pump is actuated by a six position rotary switch, allowing four positions of varying motor speed and two standby positions. The pump motor is attached to a collection kit consisting of flanges, bottles, tubing, filter, gasket, adapter caps and bottle stands. All materials in proximity to the collected milk are made of food grade plastics.
The Nurture III uses a hydrophobic filter to isolate the collected milk from the pumping mechanism. Further isolation is achieved by the air flow always being away from the collected milk to the pump mechanism, then evacuated to the atmosphere. There is never air flow from the pump to the collected milk.
It is a semi-automatic breast pump, meaning that the release of vacuum pressure is achieved by the user lifting her finger from the vent hole located on top of the collection kit. The vacuum is then built up by covering the hole.
The pump may be used with a single collection kit for the pumping of one breast, or may be used with a double collection kit for the simultaneous pumping of both breasts.
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