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510(k) Data Aggregation
K Number
K190789Device Name
IntelliCartTM System
Manufacturer
Dornoch Medical Systems
Date Cleared
2019-04-24
(28 days)
Product Code
JCX
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Dornoch Medical Systems
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IntelliCartTM System is a self-powered suction/vacuum pump intended to collect and dispose of liquid waste within Hospitals, Pathology Labs, Surgical Outpatient Centers, and Doctor's Offices.
Device Description
The IntelliCart™ System is a self-powered suction / vacuum pump intended to collect and dispose of liquid waste within hospitals, pathology labs, surgical outpatient centers, and doctor's offices. The IntelliCart™ System (System) consists of a Fluid Cart (Cart) and Evac Station (Evac). Carts are mobile devices used during surgery to collect patient fluids. Evacs are stationary devices used to process and clean Carts. The System's closed design significantly reduces employee exposure to potentially infectious surgical fluids, while eliminating up to 70% of operating room red bag waste. Carts are equipped with large volume fluid reservoirs, a single regulated vacuum pump, and a height-adjustable IV pole. A single-use manifold (REF 00-5140-201-00) serves as the interface between a Cart's fluid reservoir and sterile patient suction tubing. A Cart model equipped with a bracket to hold a Smoke Evacuator is also available. The IntelliCart™ System is a closed self-powered suction device providing various levels of suction, as selected by the user, ranging from 0-600 mmHg at maximum flow volume, and collection of up to 34L of liquid surgical waste into cart canisters equipped with a viewing window for display of canister contents shown in 100ml increments.
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K Number
K172481Device Name
IntelliCart System
Manufacturer
Dornoch Medical Systems
Date Cleared
2017-09-14
(29 days)
Product Code
JCX
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Dornoch Medical Systems
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IntelliCart™ System is a self-powered suction/vacuum pump intended to collect and dispose of liquid waste within Hospital Operating Rooms, Pathology Labs, Surgical Outpatient Centers, and Doctor's Offices.
Device Description
The IntelliCart™ System is a self-powered suction / vacuum pump intended to collect and dispose of liquid waste within hospital operating rooms, pathology labs, surgical outpatient centers, and doctor's offices.
The IntelliCart™ System (System) consists of a Fluid Cart (Cart) and Evac Station (Evac).
Carts are mobile devices used during surgery to collect patient fluids. Evacs are stationary devices used to process and clean Carts. The System's closed design significantly reduces employee exposure to potentially infectious surgical fluids, while eliminating up to 70% of operating room red bag waste.
Carts are equipped with large volume fluid reservoirs, a single regulated vacuum pump, and a height-adjustable IV pole. A single-use manifold (REF 00-5140-201-00) serves as the interface between a Cart's fluid reservoir and sterile patient suction tubing. A Cart model equipped with a bracket to hold a Smoke Evacuator is also available.
The IntelliCart™ System is a closed self-powered suction device providing various levels of suction, as selected by the user, ranging from 0-600 mmHg at maximum flow volume, and collection of up to 34L of liquid surgical waste into cart canisters equipped with a viewing window for display of canister contents shown in 100ml increments. The suction cart is portable, equipped with caster type wheels with a profile able to pass through 36 inch minimum wide doorways and allows for connection to a standard 120V/60Hz/15A facility power supply and connection to facility wall suction when necessary. Cart Canisters are integrated with a window tint feature that visually restricts canister contents during transport.
The IntelliCart™ System is operated using a back lit LCD touch screen display monitor equipped with lateral adjustment capabilities and provides digital display confirmation of total fluid capacity used as well as a functional interface for suction selection/adjustment and cart cleaning.
Single use manifolds are equipped with hydrophobic filters which turn color after wash cycle is completed, giving visual indication of a manifold which must be discarded.
The Evac Station is equipped with a coupler that connects to the Suction Cart and, using compatible bleach and enzymatic solutions to break down solid waste, empties, cleans and disinfects cart canisters. After emptying and cleaning cart canisters, the Evac Station allows for draining surgical waste into facility drains.
The IntelliCart™ System can be equipped with a powered or manual IV pole, supporting up to 12,000mL of bagged fluid and allows mounting of a compatible smoke evacuation device.
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K Number
K162421Device Name
IntelliCartTM System
Manufacturer
DORNOCH MEDICAL SYSTEMS
Date Cleared
2016-12-21
(113 days)
Product Code
JCX
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
DORNOCH MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IntelliCartTM System is a self-powered suction / vacuum pump intended to collect and dispose of liquid waste within hospital operating rooms, pathology labs, surgical outpatient centers, and doctor's Offices.
Device Description
The IntelliCartTM System is a self-powered suction / vacuum pump intended to collect and dispose of liquid waste within hospital operating rooms, pathology labs, surgical outpatient centers, and doctor's offices.
The IntelliCartTM System (System) consists of a Fluid Cart (Cart) and Evac Station (Evac).
Carts are mobile devices used during surgery to collect patient fluids. Evacs are stationary devices used to process and clean Carts. The System's closed design significantly reduces employee exposure to potentially infectious surgical fluids, while eliminating up to 70% of operating room red bag waste.
Carts are equipped with large volume fluid reservoirs, a single regulated vacuum pump, and a height-adjustable IV pole. A single-use manifold (REF 00-5140-201-00) serves as the interface between a Cart's fluid reservoir and sterile patient suction tubing. A Cart model equipped with a bracket to hold a Smoke Evacuator is also available.
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K Number
K133786Device Name
DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LID
Manufacturer
DORNOCH MEDICAL SYSTEMS, INC.
Date Cleared
2014-03-21
(99 days)
Product Code
JCX
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
DORNOCH MEDICAL SYSTEMS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dornoch Transposal Ultra System is self-powered suction / vacuum pump intended to collect and dispose of liquid waste within Hospital Operating Rooms, Pathology Labs, Surgical Outpatient Centers, and Doctor's Offices.
Device Description
The Transposal Ultra System (Ultra System) provides a closed, self-contained, reusable cylinder suction system intended to collect and dispose of waste fluids produced through surgical procedures. The Ultra System is composed of two essential components, the Ultra Suction Cart and the Ultra Evac. The Ultra Cart can be used repeatedly until either 33L (Duo) or 52L (Quad) of fluid has been collected. Once full, the Cart is moved from the OR to the Ultra Evac. The two systems are connected together with the coupler unit on the Ultra Evac. The cleaning / wash cycle is then initiated and the automatic emptving and cleaning occurs.
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K Number
K123188Device Name
DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CART WITH CL500 LID MODEL UL-DU500, DORNOC
Manufacturer
DORNOCH MEDICAL SYSTEMS, INC.
Date Cleared
2013-03-04
(144 days)
Product Code
JCX
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
DORNOCH MEDICAL SYSTEMS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dornoch Transposal Ultra System is self-powered suction / vacuum pump intended to collect and dispose of liquid waste within Hospital Operating Rooms, Pathology Labs, Surgical Outpatient Centers, and Doctor's Offices.
Device Description
The Dornoch Transposal Ultra System is self-powered suction / vacuum pump.
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K Number
K081047Device Name
TRANSPOSAL ULTRA SYSTEMS
Manufacturer
DORNOCH MEDICAL SYSTEMS, INC.
Date Cleared
2008-04-29
(15 days)
Product Code
JCX
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
DORNOCH MEDICAL SYSTEMS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dornoch Transposal Ultra System is self-powered suction / vacuum pump intended to collect and dispose of liquid waste within Hospital Operating Rooms, Pathology Labs, Surgical Outpatient Centers, and Doctor's Offices.
Device Description
The Transposal Ultra System (Ultra System) collects and disposes of waste fluids produced through surgical procedures. The Ultra System is a closed, self contained reusable suction system.
The Ultra Cart System can simultaneously collect fluids from up to four sources without mixing of the fluids. The Ultra Cart System is composed of two pieces of equipment the Transposal Ultra Cart (suction cylinder unit) and the Transposal Ultra Evac (removal and cleaning unit). The Ultra Carts can be used until 52L of fluids are collected. Once full, the Ultra Cart is attached to the Ultra Evac for automatic disposal into the hospital sanitary sewer and cleaning of the reservoir cylinders. Upon completion of the cleaning process, the cylinder lids are then replaced and the Ultra Cart is ready for use.
The Transposal Ultra Roll Stand consists of a vacuum system and up to four reusable canisters. The fluid can be collected in each canister until 2.8L of fluids are collected. The canisters are then transported to the Transposal Safety Station where they are emptied and cleaned.
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