Cool’N Carry™ Tote

Ameda HygieniKit™ Milk Collection System

Ameda HygieniKit™ Milk Collection System with Proven Airlock Protection™ is a FDA cleared class 2 medical device. It helps protect breast milk and the baby from bacteria, mold and viruses while pumping.

The Ameda HygieniKit has a patented silicone diaphragm that creates a barrier protecting the pump and pump tubing from penetration of bacteria (1,2) ''and viruses (Hepatitis B and C and Human Immunodeficiency Virus HIV)(2, 3) from contaminated liquids inside the pump body. The diaphragm in this product creates a barrier protecting liquids collected in the collecting bottle system from penetra tion of bacteria (1,2) and viruses (2,3) (Hepatitis B and C and Human Immunodeficiency Virus HIV) from the pump and tubing in the event of contamination of these components by a prior user. Note that the Ameda HygieniKit neither removes bacteria and viruses (Hepatitis B and C and Human Immunodeficiency Virus HIV) from the breast milk being fed into the collection bottle nor does the Ameda HygieniKit make it safe for infected mothers to feed their infants with milk collected using this device. 1,3 Testing performed in situ using actual HygieniKits and SMB Piston Breast Pump with suspension of Phi-X174 bacteriophage and Escherichia coli, Staphylococcus pneumoniae and Pseudomonas aeruginosa. Procedure was adopted from ASTMN 1671-97b “Standard Test method Resistance of materials Used in Protective Clothing to Penetration by Blood -borne Pathogens using Phi-X174 Bacteriophage as a test system” 2 The use of this product neither guarantees or warranties against the transmission of Hepatitis B and C and Human Immunodeficiency Virus HIV.