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510(k) Data Aggregation
K Number
K090300Device Name
MODIFICATION TO AUTOFUSER
Manufacturer
ACE MEDICAL US, LLC
Date Cleared
2009-04-30
(83 days)
Product Code
MEB
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
ACE MEDICAL US, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Autofuser family of ambulatory infusion pumps with integrated administration set, either separately or as part of a convenience kit, is intended for general infusion use. Routes of administration include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into intra-operative (soft tissue/body cavity) sites. Within the Autofuser family are pump models intended for patient-controlled infusion using the integrated bolus button. General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.
Device Description
The Autofuser system consists of a family of disposable infusion pumps and associated procedure kits. The pump is comprised of a balloon-style medication reservoir and an integrated flowrate-controlling administration set. When the Autofuser pump is packaged in a procedure kit, the kit includes legally marketed components such as filling syringe, catheter, catheter introducer, and pump carrying pouch.
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K Number
K060258Device Name
AUTOFUSER
Manufacturer
ACE MEDICAL US, LLC
Date Cleared
2006-05-30
(118 days)
Product Code
MEB
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
ACE MEDICAL US, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Autofuser family of ambulatory infusion pumps with integrated administration set, either separately or as part of a convenience kit, is intended for general infusion use. Routes of administration include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into intra-operative (soft tissue/body cavity) sites.
Within the Autofuser family are pump models intended for patient-controlled infusion using the integrated bolus button.
General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.
Device Description
The modification to the existing device is the addition of new flow rates, new reservoir size and procedure kit components.
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