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510(k) Data Aggregation
K Number
K142168Device Name
NATURE'S BOND 600 AND NATURE'S BOND 603
Manufacturer
DEVON MEDICAL PRODUCTS, INC.
Date Cleared
2014-12-04
(120 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
DEVON MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nature's Bond breast pump is a single user device intended for lactating women to express and collect milk from their breasts to complement breast feeding.
Device Description
The Nature's Bond series of breast pumps are electriconically powered suction devices used to express and collect breast milk from lactating mothers. The Nature's Bond series is comprised of two pumps, the model 600 and the model 603. The Nature's Bond breast pump system consists the pump, breast shields, tubing, power cord, bottle and cap, valve, and carrying bag exclusively for the model 603.
All available accessories are included in the Nature's Bond 600/603 package. Customers may purchase additional accessories if needed. Below is a list of all accessories included in the package:
- . 2*80mm Breast Shield
- 2*76mm Breast Shield ●
- 2*74mm Breast Shield .
- 2*Bottle .
- 2*Valve .
- . 1*Tubing
Both models of the Natuer's Bond breast pump is a software driven pump made from plastic. The details of the materials can be found in the bill of material. The pump can provide a pressure range from 0 mmHg to 206 mmHg. The model 603 has battery power (6 AA batteries) while the model 600 is only AC powered. While in using, the breast shields are in contact with human body. The device is design to be used by a single patient through one lactating period.
The device is designed for home use and is non-sterile.
Both pumps are the same in operation, use and design with the exception that the model 603 has the option to be battery powered. The pump provides intermittent suction in 6 different vacuum pressure settings to the breast to stimulate milk expression. The breast shields provide a seal around the breast to facilitate the suction. The bottles and caps are used to collect and store the milk. The tubing is used to connect the pump to the shields. The carrying bag is used to store all components when not in use.
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K Number
K110078Device Name
EXTRICARE
Manufacturer
DEVON MEDICAL PRODUCTS, INC.
Date Cleared
2012-02-10
(395 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
DEVON MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The extriCARE 2400 Negative Pressure Wound Therapy Pump System is a portable, battery powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed which may promote wound healing.
Device Description
The system consists of a vacuum pump, canister, and tubing. In operation, the device is attached via the tubing to a Negative Pressure Wound bandage. Maximum pressure and mode selection are digitally programmable. The extriCARE pump can be sold alone or as a part of the extriCARE 2400 system with extriCARE bandages. The extriCARE bandages are an all-in-one wound dressing, with no wound packing required.
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