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Found 3 results
510(k) Data Aggregation
K Number
K072921Device Name
DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM
Manufacturer
SYMBIOS MEDICAL PRODUCTS, LLC
Date Cleared
2007-11-26
(42 days)
Product Code
MEB, BSO, KGZ
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
SYMBIOS MEDICAL PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a presely for post-operative pain management.
Device Description
Not Found
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K Number
K071735Device Name
MODIFICATION TO DISPOSABLE INFUSION PUMP KIT
Manufacturer
SYMBIOS MEDICAL PRODUCTS, LLC
Date Cleared
2007-07-19
(23 days)
Product Code
MEB, BSO, KGZ
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
SYMBIOS MEDICAL PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a preset rate for post-operative pain management.
Device Description
The Symbios Disposable Infusion Pump Kit is a convenience kit that includes the components necessary to provide temporary infusion of a liquid into a patient. The components of the system are an elastomeric pump, a catheter needle/introducer, an infusion catheter and accessories. The pump is a disposable, self-contained, infusion system utilizing an inflatable elastomeric reservoir to mechanically pressurize a fluid and drive it through tubing to a small restrictor to provide infusion at a pre-set rate. The device is provided empty and no specific drug references are made in the labeling. The device is not intended for delivery of blood, blood products, lipids or fat emulsions.
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K Number
K051474Device Name
SYMBIOS DISPOSABLE INFUSION PUMP KIT
Manufacturer
SYMBIOS MEDICAL PRODUCTS, LLC
Date Cleared
2005-07-01
(28 days)
Product Code
MEB, BSO, KGZ
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
SYMBIOS MEDICAL PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management.
The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a proset rate for post-operative pain management.
Device Description
The Symbios Disposable Infusion Pump Kit is a convenience kit that includes the components necessary to provide temporary infusion of a liquid into a patient. The components of the system are an elastomeric pump, a catheter needle/introducer, an infusion catheter and a bandage. The pump is a disposable, self-contained, infusion system utilizing an inflatable elastomeric reservoir to mechanically pressurize a fluid and drive it through tubing to a small restrictor to provide infusion at a pre-set rate.
The device is provided empty and no specific drug references are made in the labeling. The device is not intended for delivery of blood, blood products, lipids or fat emulsions.
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