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510(k) Data Aggregation
K Number
K993797Device Name
EC-7701 FLUID WARMING CABINET
Manufacturer
ENTHERMICS MEDICAL SYSTEMS, INC.
Date Cleared
2000-01-20
(72 days)
Product Code
LDQ, LDO
Regulation Number
N/AWhy did this record match?
Product Code :
LDQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Enthermics Medical Systems EC-7701 Fluid Warming Cabinet is designed to safely store and warm irrigation fluids or injection fluids in accordance with the recommended warming temperatures and storage times stated in the fluid manufacturers' labeling.
Device Description
The EC-7701 is a stainless steel fluid warming cabinet that utilizes a fully insulated electrothermal cable array that is wrapped inside the bottom and two sides of the cabinet to provide uniform radiant, conductive and convective heating. The device can be used to heat irrigation fluids to a temperature ranging from 90°F to 150°F, or injection fluids to a range of 90°F to 110°F. The device also contains an over-temperature alarm which provides an audible and visual alarm when the internal temperature reaches 10°F above the selected temperature.
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K Number
K992258Device Name
HOT SHOT FLUID WARMER IV FLUIDS
Manufacturer
INFRA-MED TECHNOLOGIES, INC.
Date Cleared
2000-01-12
(190 days)
Product Code
LDQ
Regulation Number
N/AWhy did this record match?
Product Code :
LDQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Warm intravenous fluids.
Device Description
HOT SHOT™ FLUID WARMER IV FLUIDS
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K Number
K981032Device Name
PIV SYSTEM
Manufacturer
MEDICAL SOLUTIONS, INC.
Date Cleared
1998-09-02
(167 days)
Product Code
LDQ
Regulation Number
N/AWhy did this record match?
Product Code :
LDQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medical Solutions PIV IV Bag Warmer and Pressure Infusor is designed to hold and heat IV fluid bags and maintain temperatures to 980 F ( 3°F). It is also a pressure infusor designed to be inflated to increase pressure on the IV bag to assist the infusion of fluid.
Device Description
Not Found
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K Number
K973747Device Name
CONTROLLED TEMPERATURE CABINET SYSTEM
Manufacturer
SMITH
Date Cleared
1998-05-07
(218 days)
Product Code
LDQ
Regulation Number
N/AWhy did this record match?
Product Code :
LDQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medical Products, Inc. Controlled Temperature Cabinet Systems are designed to store and maintain the temperature of drugs and I.V. solutions in the ambulance or mobile vehicle environment to temperatures between 21º to 26ºC or 35º to 40ºC.
The Controlled Temperature Cabinet Systems must be ordered by temperature range. For drugs the range is 210 to 26°C and for I.V. solutions the temperature range is 35°co 40°C.
Warning: The owner of the ambulance or mobile vehicle should contact the manufacturer of the products to be placed inside the cabinets and obtain guidelines for exposing their product to temperatures other than those stated on the I.V. solution bag/bottle or drug container.
Device Description
Controlled Temperature Cabinet System
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K Number
K955661Device Name
ACU-HALT
Manufacturer
GLEDERER & CO., INC.
Date Cleared
1996-12-30
(384 days)
Product Code
LDQ
Regulation Number
N/AWhy did this record match?
Product Code :
LDQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K955776Device Name
ACU-LAB
Manufacturer
GLEDERER & CO., INC.
Date Cleared
1996-06-05
(168 days)
Product Code
LDQ
Regulation Number
N/AWhy did this record match?
Product Code :
LDQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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