Address:2021 Airport Road,Conroe,TX,77301,US
Device Description : A small, noninvasive, closed-ended Luer attachment intended to be attached to a A small, noninvasive, closed-ended Luer attachment intended to be attached to a luminal device (e.g., catheter, intravenous administration or pressure-monitoring tubing, syringe) with a Luer connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A non-sterile device designed to connect together two or more tubes typically wi A non-sterile device designed to connect together two or more tubes typically with the intention of creating an extension. The connecting ends of this device will typically be serrated to provide a secure grip for the applied tubes. Clips or other forms of locking devices may be applied over the tubes to further secure the fitting. This device will not be appropriate for connecting tubes that are designed to carry (withstand) high pressures [e.g., high pressure gases]. This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A sterile, hand-held manual surgical instrument designed to directly compress a A sterile, hand-held manual surgical instrument designed to directly compress a blood vessel (vein or artery) to create a temporary haemostasis (arrest or prevention of bleeding). It typically has a self-clamping, bulldog-like or scissors-like, ring-handled design with serrated jaws; the working end has blades of various designs (e.g., straight or angled). It is available in various sizes and is typically made of plastic materials. This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : No
Prescription Use : No
Device Description : A hand-held surgical instrument designed to compress the severed end of a small A hand-held surgical instrument designed to compress the severed end of a small vessel (e.g., blood vessel, vas deferens) to occlude the vessel, typically prior to anastomosis formation. Often referred to as an Acland clamp, it has an A-/V-shaped design whereby the vessel is slid into the mouth of the clamp up to the apex where it is compressed; it does not have a hinge/jaws (i.e., it is not forceps or a bulldog clamp). This is a reusable device intended to be sterilized prior to use.
Device Class :
Duns Number: 938289980
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : No
Prescription Use : No
Device Description : A sharp bevel-edged, hollow tubular metal instrument designed to remove fluid fr A sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A sterile, single lumen, tubular device designed to deliver cardioplegic solutio A sterile, single lumen, tubular device designed to deliver cardioplegic solution to the aortic root to stop the beating of the heart and maintain it dormant; it may also be used to vent the aorta and the left heart during a cardiopulmonary bypass procedure. It is typically made of plastic [e.g., polypropylene, polyvinyl chloride (PVC)] with a soft insertion tip and a suture flange for its anchoring; it may have one or more tubes (a second for aspiration, if needed), and typically Luer connector(s) for connection to the infusion syringe and aspiration line(s). It may include a manual tubing clamp and insertion is typically achieved with a removable stylet. This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : No
Prescription Use : No
Device Description : A single lumen, tubular device designed to deliver cardioplegic solution to the A single lumen, tubular device designed to deliver cardioplegic solution to the aortic root to stop the beating of the heart and maintain it dormant; it may also be used to vent the aorta and the left heart during a cardiopulmonary bypass procedure. It is typically made of plastic [e.g., polypropylene, polyvinyl chloride (PVC)] with a soft insertion tip and a suture flange for its anchoring; it may have one or more tubes (a second for aspiration, if needed), and typically Luer connector(s) for connection to the infusion syringe and aspiration line(s). It may include a manual tubing clamp and insertion is typically achieved with a removable stylet. This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A sterile, porous device used in the arterial line of an extracorporeal circuit, A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : No
Prescription Use : No