Search Results
Found 3 results
510(k) Data Aggregation
K Number
K991594Device Name
CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS
Manufacturer
SANGSTAT MEDICAL CORP.
Date Cleared
1999-08-05
(90 days)
Product Code
MSB
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
SANGSTAT MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Celsior™ is intended for flushing and cold storage of a heart at the time of its removal from a donor in preparation for storage, transportation, and eventual transplantation into a recipient.
Device Description
Celsior (SangStat Medical Corporation, Fremont, CA) is a clear to slightly yellow, sterile, non-pyrogenic, extracellular solution for hypothermic flushing and storage of hearts. The solution is slightly acidic (pH 7.3 + 0.10), slightly hypertonic (osmolarity 320-360 mOsmol) with low viscosity (1.15 cSt), and has a high buffering capacity (acidic approximately 11 mmol, alkaline approximately 7 mmol). The composition of Celsior is thus consistent with that of an extracellular solution.
Celsior is filled into 1 liter ethylene-vinyl acetate copolymer (EVA) bags. The EVA bags are sterilized (ethylene oxide) and aseptically filled up to 1,000 mL in a sterile area. After filling, each EVA bag is enveloped by an aluminum protected bag containing an oxygen absorbent sachet. This product must be stored under refrigerated conditions at 2° to 8°C (36° to 46°F) until it is used.
Ask a Question
K Number
K973203Device Name
THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES
Manufacturer
SANGSTAT MEDICAL CORP.
Date Cleared
1998-09-30
(400 days)
Product Code
DAK
Regulation Number
866.5240Why did this record match?
Applicant Name (Manufacturer) :
SANGSTAT MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ThymoStat™ is a qualitative plate ELISA for the detection of human anti-rabbit antibodies in human serum. The presence of human anti-rabbit antibodies has been associated with patients receiving injections of rabbit antibodies for therapeutic purposes.
Device Description
Not Found
Ask a Question
K Number
K980109Device Name
CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER
Manufacturer
SANGSTAT MEDICAL CORP.
Date Cleared
1998-08-18
(218 days)
Product Code
KYX
Regulation Number
880.6430Why did this record match?
Applicant Name (Manufacturer) :
SANGSTAT MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CycloTech™ Cyclosporine Oral Solution Dispenser (Dispenser) is intended to dispense SangCya™ cyclosporine oral solution USP (for microdispersion) as well as display and store dose size, time to next dose, remaining available doses, and doses dispensed.
Device Description
CycloTech™ is designed for use with a standard fifty (50) mL bottle. A disposable fluid path, fully enclosed by the outer plastic shell, has a 0.1 to 5.0 mL dose range with 0.1 mL per step resolution and an accuracy of plus or minus five percent (+ 5%) for dispensed volumes. This device has two (2) user buttons, a custom LCD display, one (1) year memory at two (2) doses per day (uploadable to a PC), six (6) months battery life using common AA-type alkaline batteries, and pump technology for a specified volume range.
Use of a pump mechanism and microcomputer allows control of fluid delivery. The primary system upon which this product is based is the gravimetric principle of fluid delivery. The pump mechanism is used to assist the microcomputer in measuring amounts of liquid cyclosporine as well as dispensing the medication. The microcomputer, taking into account fluid viscosity, is able to provide an accurate, reproducible amount of liquid medication.
CycloTech™ is comprised of a molded plastic case assembly with an interchangeable disposable fluid path assembly. The fluid path assembly will only accept the original container of cyclosporine oral solution obtained from the drug manufacturer (reservoir or medication supply bottle). The case assembly provides for setting or adjusting the amount of liquid delivered, for measuring time, and for storing data. This apparatus also provides visual and audio output to the user, a control processor for monitoring and recording the time and number of dispensed doses of medication, a method for alerting a user of the time for taking their dose(s) of medicine, and monitoring the amount of medication remaining in the fluid path and reservoir. Audio alarms for alerting a user are also included in the Dispenser. The control processor, via interface, may be linked with an external computer. A liquid dispensing valve assembly and pump are used for dispensing liquid medicines from the reservoir through the fluid path assembly.
Ask a Question
Page 1 of 1