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Found 6 results
510(k) Data Aggregation
K Number
K052221Device Name
AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP
Manufacturer
SORENSON MEDICAL, INC.
Date Cleared
2005-12-08
(115 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
SORENSON MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ambIT® "PreSet" Ambulatory Infusion Pump is intended for use by surgeons and anesthesiologists for the perioperative and post operative infusion of local anesthetics and narcotics for pain management and regional anesthesia.
Routes of administration include intravenous, subcutaneous, intramuscular, perineural and epidural.
The ambIT® "PreSet" Ambulatory Infusion Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
Device Description
Sorenson Medical's ambIT® PreSet Ambulatory Infusion Pump is compact, lightweight, microcomputer-controlled pumps that use rotary peristaltic pumping technology. The amblT® PreSet Ambulatory Infusion Pump differs only slightly from the Palm Pump (K002434) already marketed. Changes have been made to that pump to incorporate a modified printed circuit board and a software revision to provide for ease of pump programming by the user.
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K Number
K033325Device Name
AMBIT CONTINUOUS AMBULATORY INFUSION PUMP
Manufacturer
SORENSON MEDICAL, INC.
Date Cleared
2003-11-06
(21 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
SORENSON MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ambIT™ Infusion Pump is intended for continuous volumetric delivery of intravenous medicines and/or fluids into patients at a consistent volume for prescriptive treatment by a physician.
Device Description
Sorenson Medical's amblT™ Continuous Ambulatory Infusion Pump is compact, lightweight, microcomputer-controlled pumps that use rotary peristaltic pumping technology. The modified device differs only slightly from the Palm Pumps (K002434) already marketed. Changes have been made to that pump to incorporate three roller gears instead of two, a modified PCB, a change to color and name, and a software revision to provide for continuous fluid delivery to specified output requirements
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K Number
K033425Device Name
AMBIT INTERMITTENT AMBULATORY INFUSION PUMP
Manufacturer
SORENSON MEDICAL, INC.
Date Cleared
2003-11-06
(10 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
SORENSON MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ambIT™ Intermittent Ambulatory Infusion Pump is intended for the Intermittent volumetric delivery of intravenous medicines and/or fluids into patients at a preset rates and volumes for prescriptive treatment by a physician.
Device Description
Sorenson Medical's amblT™ Intermittent Ambulatory Infusion Pump is compact, lightweight, microcomputer-controlled pumps that use rotary peristaltic pumping technology. The modified device differs only slightly from the Palm Pumps (K002434) already marketed. Changes have been made to that pump to incorporate three roller gears instead of two, a modified PCB, a change to color and name, and a software revision to provide for intermittent fluid delivery to specified output requirements.
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K Number
K002434Device Name
PALM PUMP
Manufacturer
SORENSON MEDICAL, INC.
Date Cleared
2000-08-23
(14 days)
Product Code
MEA
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
SORENSON MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001287Device Name
EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML
Manufacturer
SORENSON MEDICAL, INC.
Date Cleared
2000-06-09
(46 days)
Product Code
KPE
Regulation Number
880.5025Why did this record match?
Applicant Name (Manufacturer) :
SORENSON MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991363Device Name
30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU
Manufacturer
SORENSON MEDICAL, INC.
Date Cleared
1999-05-13
(23 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
SORENSON MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
All Pumps are for the infusion of fluids and medications into a body. The 30 Pump is for infusion at a continuous low flow rate. The 200 Pump is for intermittent doses with a keep vein open (KVO) rate between doses, as well as continuous or KVO only capabilities. The PCA Pump is for pain management by intravenous and epidural infusion of fluids and medications. The PCEA Pump is marketed for epidural infusion of fluids and medication for pain management; but the PCEA model can also be used for intravenous infusion as well.
Device Description
Not Found
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