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510(k) Data Aggregation
K Number
K082182Device Name
AP 34 MULTI-THERAPY INFUSION PUMP
Manufacturer
Q-CORE, LTD
Date Cleared
2008-08-15
(14 days)
Product Code
FRN, FPA, MRZ
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
Q-CORE, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AP 34 is a multi-therapy infusion pump system designed for the volumetric infusion of medication and nutritional fluids to patients in the hospital, homecare and outpatient environments in the following delivery modes: CONTINUOUS; INTERMITTENT; PCA (Patient Control Analgesia) and TPN (Total Parenteral Nutrition). The AP 34 is not intended for the following use or substances:
- Delivery of blood or cellular blood products .
- . Intra-cardiac use.
The AP 34 infusion pump includes the following accessories:
- Bolus cable .
- Q--Core approved AC/DC adaptor (external)] .
- Cradle (optional) and power cable for cradle .
- Rechargeable battery pack for pump .
- . PCA cover box
- Communication cables .
The dedicated Q-Core Administration Sets for the AP 34 infusion pump are intended for single-patient use only.
The AP 34 infusion pump system is for prescription use only.
Device Description
The Q-CORE AP 34 multi-therapy Infusion Pump is a software driven, volumetric, ambulatory infusion pump for the delivery of measured amounts of medication or parenteral nutrition at a controlled rate. The AP 34 uses Q-Core approved disposable Administration Sets, including the Q-Core designed Magic Straw™ cassette. The AP 34 operates by means of an electro-mechanical pumping mechanism based on Q-Core patented Electromagnetic Flow Control (EFC™) valve technology. The pumping mechanism is a single channel, with an integral pressure sensor and real time flow correction capacity; the pumping mechanism produces a peristaltic pumping action.
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