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Found 9 results
510(k) Data Aggregation
K Number
K080954Device Name
T34L SYRINGE DRIVER
Manufacturer
CAESAREA MEDICAL ELECTRONICS LTD.
Date Cleared
2008-05-16
(43 days)
Product Code
FRN, FPA, MEA
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
CAESAREA MEDICAL ELECTRONICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The T34L SYRINGE DRIVER is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely controlled infusion rates through all clinically acceptable routes of administration including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general fluids therapy in hospital and home care environments.
Device Description
The T34L SYRINGE DRIVER SYSTEM includes: Syringe Pump External Charger Extension Tube Bolus cable (optional)
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K Number
K070235Device Name
BODYGUARD PAIN MANAGER INFUSION SYSTEM
Manufacturer
CAESAREA MEDICAL ELECTRONICS LTD.
Date Cleared
2007-05-18
(113 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
CAESAREA MEDICAL ELECTRONICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BodyGuard infusion Pump system is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes, of administration, including intravenous, subcutaneous, percutaneous, intraarterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general fluids therapy in hospital and home care environments.
Device Description
The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets (Microset/ BodySet) Bolus cable (optional) Drop sensor (optional)
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K Number
K070718Device Name
MODIFICATION TO: BODYGUARD INFUSION SYSTEM
Manufacturer
CAESAREA MEDICAL ELECTRONICS LTD.
Date Cleared
2007-04-13
(30 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
CAESAREA MEDICAL ELECTRONICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BodyGuard Infusion system is designed to transfer medication and fluids intravenously. The system is intended for patients who require maintenance medications, PCA therapy, Parenteral nutritional fluids and general I.V. fluids therapy in hospital and home care environments.
Device Description
The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets PCA cable (optional) Charging cable (optional)
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K Number
K061325Device Name
BODYGAURD PAIN MANAGER INFUSION SYSTEM
Manufacturer
CAESAREA MEDICAL ELECTRONICS LTD.
Date Cleared
2006-08-24
(105 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
CAESAREA MEDICAL ELECTRONICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BodyGuard Infusion system is designed to transfer medication and fluids intravenously. The system is intended for patients who require maintenance medications in hospital and home care environments. The system is intended for delivery of patient controlled analgesia (PCA) The system is intended for delivery of pain therapy (EPIDURAL)
Device Description
Not Found
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K Number
K060479Device Name
MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM
Manufacturer
CAESAREA MEDICAL ELECTRONICS LTD.
Date Cleared
2006-05-12
(78 days)
Product Code
FRN, DOA
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
CAESAREA MEDICAL ELECTRONICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BodyGuard infusion Pump system is designed for infusion and monitoring. The pump is intended for infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). Monitoring accessory currently includes Pulse Oximeter, used for non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general fluids therapy. The system is indicated for use with adult, pediatric and neonatal patients in hospital and home care environments.
Device Description
The BodyGuard Infusion system includes: Infusion Pump (one/dual channel models) Docking Station Bolus cable (optional) Drop sensor (optional) Pulse Oximeter (optional)
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K Number
K050800Device Name
NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS
Manufacturer
CAESAREA MEDICAL ELECTRONICS LTD.
Date Cleared
2005-11-23
(238 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
CAESAREA MEDICAL ELECTRONICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The T34 SYRINGE DRIVER is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely controlled infusion rates through all clinically acceptable routes of administration including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general fluids therapy in hospital and home care environments.
Device Description
The T34 SYRINGE DRIVER SYSTEM includes: Syringe Pump Extension Tube Bolus cable (optional)
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K Number
K042696Device Name
BODYGUARD INFUSION PUMP SYSTEM
Manufacturer
CAESAREA MEDICAL ELECTRONICS LTD.
Date Cleared
2005-03-11
(162 days)
Product Code
FRN, FPA, MEA
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
CAESAREA MEDICAL ELECTRONICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BodyGuard infusion Pump system is designed for infusion of continuous or intermittent delivery at medically-controlled infusion rates through clinically acceptable routes of administration (e.g. intravenous, subcutaneous, percutaneous, intraarterial, epidural, enteral, in close proximity to nerves, and into an arterial, regional, or surgical wound site). The system is intended for patients who require maintenance medications, analgesics, parenteral and enteral nutrition fluids, chemotherapeutic agents or PCA therapy; parenteral fluids therapy in hospital and home care environments.
Device Description
The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets (Microset/ BodySet) Bolus cable (optional) Drop sensor (optional)
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K Number
K040957Device Name
NOA III ENTERAL NUTRITION PUMP
Manufacturer
CAESAREA MEDICAL ELECTRONICS LTD.
Date Cleared
2004-05-21
(38 days)
Product Code
LZH
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
CAESAREA MEDICAL ELECTRONICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NOA III Enteral Nutrition Pump is designed to deliver programmed doses of enteral nutrition solutions at selected rates. The pump is designed to be used in hospital and home care environments. The pump can be used in stationary and ambulatory ways.
Device Description
The NOA III Enteral Nutrition System includes: Infusion Pump, Battery Charger.
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K Number
K031749Device Name
BODYGUARD INFUSION SYSTEM
Manufacturer
CAESAREA MEDICAL ELECTRONICS LTD.
Date Cleared
2003-08-21
(77 days)
Product Code
FRN, FPA
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
CAESAREA MEDICAL ELECTRONICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BodyGuard Infusion system is designed to transfer medication and fluids intravenously. The system is intended for patients who require maintenance medications, PCA therapy, Parenteral nutritional fluids and general I.V. fluids therapy in hospital and home care environments.
Device Description
The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets (Microset/ BodySet female luer) PCA cable (optional) Charging cable (optional)
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