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510(k) Data Aggregation
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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