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510(k) Data Aggregation
K Number
K122483Device Name
PEARL DIABETES MANAGEMENT SYSTEM
Manufacturer
Date Cleared
2013-01-03
(142 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
Asante Solutions, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pearl™ Diabetes Management System is intended for continuous, subcutaneous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in adult patients requiring insulin.
Device Description
The Pearl™ Diabetes Management System is a continuous, programmable insulin delivery system. It consists of a controller, a single use pump body and an infusion set adapter. The controller unit has a user interface to program delivery parameters for basal and bolus insulin delivery. It attaches to the pump body. The pump body provides the drive mechanism and battery power and holds the pre-filled insulin cartridges. The infusion set adapter is the conduit from the insulin cartridge to the final delivery tubing.
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