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510(k) Data Aggregation
K Number
K070844Device Name
NILIMEDIX ADI
Manufacturer
Date Cleared
2008-06-06
(437 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
NILIMEDIX LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NiliMedix ADI insulin pump is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
Device Description
The NiliMedix ADI Insulin Pump is an ambulatory, battery operated, rate programmable micro infusion pump, designed for continuous delivery of insulin. A custom reservoir is driven by the insulin pressure to deliver preset basal profiles and patient programmed bolus of insulin through FDA cleared infusion sets into subcutaneous tissue. The ADI pump is restricted to sale by, or on the order of a physician.
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