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510(k) Data Aggregation
K Number
K122686Device Name
ACCU-CHEK ULTRAFLEX INFUSION SET
Manufacturer
Date Cleared
2012-11-16
(73 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
ROCHE DIABETES CARE AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ACCU-CHEK® Ultraflex is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.
Device Description
The ACCU-CHEK Ultraflex is an ethylene oxide sterilized, single-use, disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The infusion set includes a stainless steel introducer needle to facilitate insertion of the soft cannula into the dermis. The unit is designed to interface with commercially available insulin infusion pumps with suitable luer connections. The insulin infusion pump systems are designed to control the delivery of U100 insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus.
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