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510(k) Data Aggregation
K Number
K983624Device Name
GILTECH PLUS CONNECTING TUBE SET
Manufacturer
GILTECH PLUS, INC.
Date Cleared
1999-03-18
(154 days)
Product Code
KDH
Regulation Number
876.5980Why did this record match?
Product Code :
KDH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Giltech Plus Connecting Tube Sets will consist of: (a) Insufflation Tubing Sets (b) Suction / Irrigation Sets (c) Urinary Extension Tubing (d) Tubing Sets necessary to connect two devices, however never to be used to transmit a gas or a liquid for intravenous or intramuscular transmission.
Device Description
Not Found
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K Number
K981286Device Name
SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS
Manufacturer
ARMM, INC.
Date Cleared
1998-06-19
(72 days)
Product Code
KDH
Regulation Number
876.5980Why did this record match?
Product Code :
KDH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The irrigation tubing sets will be used to flush and instill fluids into sites so that visibility is maintained for the operating team. The sets will be attached to standard irrigation systems such as either gravity bag systems attached to I.V. standard neiganian a pump systems that use pressurized bottles instead of the gravity fed bags as the source of the irrigant. The handle or accessory for irrigation would be attached to the end opposite the irrigant source.
The aspiration tubing sets will be used for the removal of fluids, air or debris left I fie aspiration the surgery. These sets could be used just to remove the flushing irrigant that is used to keep the surgical arena visible. One ond would be attached to the suction source and the other end would be attached to the suction tip handle.
Device Description
The irrigation sets will be offered in different sizes with spikes and luer locks for attachments to the gravity bag feed systems. There would be four different size attaching to the grate to allow the customer to chose the most economical set according to what their requirements are. There would be one dual set with a wye and two pinch clamps to allow for the use of two supply bags. There would w one set offered with valves for the use of the bottle type supply systems so that clamps would not have to be activated for operation.
The aspiration tubing sets will be offered in different sizes with suction I no aspreaten and luer locks for those smaller sizes that require them for hooking them to the suction system. The larger sizes may be used by just pushing the tubing over the barbed connectors on the suction supply systems.
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K Number
K971259Device Name
COMBIPORT FLUID LAVAGE DEVICE
Manufacturer
B. BRAUN MEDICAL, INC.
Date Cleared
1997-10-27
(206 days)
Product Code
KDH
Regulation Number
876.5980Why did this record match?
Product Code :
KDH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FUID LAVAGE DEVICE THE COMBIPORT TO FLUSH FLUID INTO IS INTENDED DURING GASTRIC LAVAGE THE STOMACH PROCEDURES.
Device Description
The CombiPort is a device intended to fluid into the stomach during gastric lavage procedure.
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K Number
K962850Device Name
TUM-E-VAC
Manufacturer
ETHOX CORP.
Date Cleared
1997-02-21
(214 days)
Product Code
KDH
Regulation Number
876.5980Why did this record match?
Product Code :
KDH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Comparable to single tube Gastric lavage and stomach evacuator tubes.
Disposable, non-sterile tube for gastric lavage.
The lavage tube is used as a two way conduit from a lavage bag set to the stomach.
Device Description
The tube is made of a flexible PVC that is easy to insert and comfortable for the patient. Water is released from a fluid source and flows into the stomach. The larger the tube, depending on patient age, the quicker the lavage can be completed. Once in the stomach, the water is drawn back up the tube and into a drainage bag. Pill fragments from the overdose are part of the discharged fluid. The extra port in the lavage tube simply allows better "back and forth" flow. This is done by allowing air to quickly replace the fluid drawn out during drainage.
The dual lumen lavage tube is an improvement to Ethox's current tubes to allow a quicker lavage. The extra lumen is a small diameter airway that acts as a vent allowing the lavage fluid in the main tube to pass in and out of the stomach without any "vapor lock" action.
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