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510(k) Data Aggregation
K Number
K223084Device Name
MilkMate Breast Pump
Manufacturer
Date Cleared
2023-03-16
(167 days)
Product Code
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
MilkMate Products, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MilkMate Breast Pump is intended to be used by lactating women to express and collect milk from their breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. It is intended for multiple users in places of work, shared spaces, healthcare facilities, hospitals, and the home.
Device Description
The MilkMate Breast Pump includes a multi-user breast pump and disposable breast pump kits for the convenience of pumping in the workplace, shared spaces, healthcare facilities, hospitals, or the home environment.
The breast pump provides two modes: stimulation and expression mode. It can be operated using AC power or a built-in rechargeable li-ion cylindrical battery.
The kits are comprised of two each of a breast shield, breast shield body, backflow protector, valve and membrane, standard neck bottle pouch with cap, tubing, and tubing connector. Three breast shield sizes are offered (27 mm, 30 mm, and 36 mm). The kits are pre-assembled and sterile.
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