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The Safety Sliding Blood Collection Set is intention into a patient's vascular system for blood collection or short term (up to 2 hours) IV administration, by a trained medical professional. It aids in the prevention of accidental needle stick through the use of an active safety feature.

Components of the subject device include: (1) Needle cap, (2) Butterfly wings, (3) Safety shield, (4) Needle, (5) Flexible tube, (6) Female luer (adapter), (7) Male luer hub, (8) Puncture needle, (9) Rubber sleeve, (10) Puncture needle protect cover, (11) Holder, (12) Protective cap. The subject device has three configurations: with Holder, with Holder, without Male Adapter. Each configuration has all of the (1) - (6) components mentioned above. The difference between the three configurations is that they have only one or more of the (7) – (12) components mentioned above. The proposed device is available various needle size and flexible tube length. The range of needle size is from 25G (0.5mm) to 20G (0.9mm). The range of flexible tube length is from 10cm (4") to 30cm (12"). The subject device has sharps injury protection features. It aids in the prevention of accidental needle stick through the use of an active safety feature. The subject device is a sterile, single use device. It is sterilized by Ethylene Oxide Gas (EtO) to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years. No DEHP, BPA and Natural Rubber Latex are added in the proposed device.

The ENFit Adaptor is intended for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel.

To facilitate the interconnection between newly-released feeding sets, which are equipped with female ENFit connectors, and the funnel feeding ports of previously-designed enteral feeding tubes, the proposed device is designed with the mating component of an ENFit female connector, designed and tested in accordance with ISO 80369-3 and ISO 80369-20, at one of its ends, and the mating component of a non-ISO 80369-1 compliant funnel feeding port, a stepped tip connector, at its other end. It can prevent an interruption or delay in patient care by allowing fitment of enteral feeding sets with ISO 80369-3 compliant ENFit female connectors to existing enteral feeding tubes with non-ISO 80369-1 compliant end connectors, referred to as "funnel feeding ports" which are still available for use in healthcare setting. The proposed device is sterile or non-sterile device is sterilized by ethylene oxide to achieve a SAL 10- and supplied in sterility maintenance package which maintain the sterility of the device during the shelf life 5 years. No DEHP, BPA and Natural Rubber Latex are added in the device.

Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.

The proposed device, Pen Needle, is designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. It is provided sterile, single use. The proposed device consists of four components, which are 1) Needle Container 2) Needle Shield 3) Needle Tube and 4) Needle Hub. Needle Container, together with Sealed Paper can forming the unit packaging of Pen Needle, that maintains the sterility of Pen Needle Hub can be connected screwed onto the pen injectors.

The Vented Vial Transfer Pin is intended for the transfer and mixing of drugs contained in a vial.

The proposed device consists of five components: (1) Protective cap, (2) Piercing spike, (3) Filter medium, (4) Filter shell, (5) Luer connector cap. The piercing spike contains the dual lumen channel for liquid and air. A 0.2um hydrophobic air filter medium is assembled to the end of air channel. This enables keeping an equilibrium pressure between the drug vial and the ambient pressure, filtering the inserted/released air through filter medium. There is a female Luer lock connector in the end of liquid channel, it can be attached a device with a male Luer connector (e.g., standard syringe). The proposed device is available 2 specifications according to design, with security clip and without security clip. The Vented Vial Transfer Pin with Security Clip designed which can be fixed to a 13mm drug vial to prevent accidental separation. The proposed device is a sterile, single use device. It is sterilized by Ethylene Oxide Gas (EtO) to achieve a SAL of 106 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years. No DEHP, BPA and Natural Rubber Latex are added in the proposed device.

Single use O-ring gasket syringe with ENFit connector (provided sterile and non-sterile): The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used in clinical settings by users ranging from clinicians to laypersons in all age groups. Reusable O-ring gasket syringe with ENFit connector-(provided non-sterile): The device is indicated for use as a dispenser, a measuring device. It is used to deliver fluids into the body orally or enterally. It is intended to be used multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only.

The proposed device is manual feeding syringe, used as a dispenser, a measuring device, and a fluid transfer device. And it is used to deliver fluids into the body orally or enterally in clinical and non-clinical settings. There are 2 types of connector for proposed device: Low dose tip ENFit connector(1ml to 6ml) and Standard ENFit connector(12ml to 60ml). The proposed device is standard piston syringe consisting of a plastic hollow barrel with female ENFit connector of ISO 80369-3, plunger, 0-ring piston, Connector of 1ml and 3ml syringe situated centrally, connector of other syringe situated eccentrically. All connectors are compatible only with enteral access or accessories having male ENFit connector of ISO 80369-3. The proposed syringes are available in transparent barrel and amber barrel. The proposed device is provided sterile or non-sterile, single use or reusable. The sterile device is sterilized by Ethylene Oxide Gas (EtO) to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life. The reusable device is for single patient use only. The proposed device is made with polypropylene and Silica gel. No DEHP, BPA and Natural Rubber Latex are added in the proposed device. The proposed device also has an optional syringe tip cap.

The Pump Alignment Syringe is intended for use by healthcare professionals for injection of fluids for medical purposes into patients of all ages, including neonates in a controlled manner with compatible infusion pumps. The Pump Alignment Syringe can also be used for manual injection of fluids for medical purposes.

The Pump Alignment Syringe is available in various specifications, including 3ml, 5ml, 10ml, 30ml and 60ml. The proposed device consists of three components: (1) plunger, (2) piston, (3) barrel. The connector of barrel have two types of luer-lock and luer-slip. The proposed device is provided sterile. The product is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.

The Pre-filled Syringe with Saline is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.

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Enteral Pump Syringe delivers nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow. Enteral Pump Syringe is intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to health care professionals, to administer nutritional formula. In particular, these syringes can be connected with enteral infusion pump. Enteral Pump Syringe is intended for neonatal, pediatric and adult use. Enteral Pump Syringe is single use device.

The proposed device is modified device of K190502(ENFit Oral/Enteral Syringe,cleared July 2, 2019) according to 21CFR 820.30. The change is a operation mode change from manual use to use with infusion pump. The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 1ml to 60ml. The ENFit enteral feeding syringe consists of moveable plunger, piston, calibrated hollow barrel and tip cap(not necessary). At the distal end of the barrel is a female connector, designed according to ISO 80369-3 (often referred to as an ENFit connection). The tip is designed to mate only with enteral administration devices and is incompatible with Luer connectors. The device is used to deliver fluids into the body enterally by connected to an enteral access device with male ENFit connector. The syringes (size 6ml to 60ml) incorporate a female Standard ENFit connector; the syringes (size 1ml and 6ml) incorporate a female low dosing ENFit connector. There are 2 types of ENFit connector ENFit syringe and central connector ENFit syringe. The sizes of the Side connector ENFit syringe range from 12ml to 60ml; and The sizes of the central connector ENFit syringe range from 1ml to 60ml. The syringes are provided with transparent or amber color barrel. The material used of deviec are Polypropylene. Polyisoprene rubber, Polydimethysiloxane(inside surface coating of barrel ). Amber additive(for used amber color barrel only), which are also patient-contacting materials for the proposed devices. The time of contact duration is less than 24 hours. The contact level is mucosal membrane, indirect. The proposed device is sterile or non-sterile, single use. The sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years. The proposed device intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to health care professionals. The device has no energy in itself. But the syringe works with infusion pump and extension sets.The syringe is aspirated nutritional formula liquid, connected the extension set. Then user installed it on the infusion pump, and pump fluids into a body enterally in a controlled manner for administer enteral nutrition. The accuracy of graduations for enteral syringes is +/- 4% of expelled volume.

Huber Needle Infusion Set: The Huber Needle Infusion Set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port. The 19G-22G needles of device are also suitable for power injection of contrast media to a maximum pressure of 325psi. When used with ports indicated for power injection, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G, 2ml/s for 22G. Safety Huber Needle Infusion Set: The Safety Huber Needle Infusion Set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port. The safety feature is manually activated during needle removal, and in the prevention of accidental needle sticks. The 19G-22G needles of device are also suitable for power injection of contrast media to a maximum pressure of 325psi. When used with ports indicated for power injection, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G, 2ml/s for 22G.

The Huber Needle Infusion Set and Safety Huber Needle Infusion Set non-coring angled needle are single use, sterile and non-pyrogenic device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. The Huber Needle Infusion Set and Safety Huber Needle Infusion Set are available in different gauge sizes (25G, 24G, 22G, 20G, 19G) and length (0.5", 0.75", 1.0", 1.24", 1.5"). The 19G-22G needles of device are suitable for power injection of contrast media into the central venous system only through an implanted port that is indicated for power injection at a maximum pressure of 325psi. For power injection of contrast media, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G and 2ml/s for 22G.The 24G and 25G needles of device should not be used with power injectors. The Huber Needle Infusion Set is available in five models (S-1, S-2, Y-1, Y-2, D-1), and the Safety Huber Needle Infusion Set is available in four models (S-1s, S-2s, Y-1s, Y-2s). The safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlestick. After activation, the non-coring needle is locked in the safety mechanism-plate. The device also have Y-sites with Y-needleless adapters or Y-needle adapters for secondary access. The needleless adapters eliminate the risk of needlestick.

The Blood Collection Needle with/without holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The Safety Blood Collection Needle with/without holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. The Luer access device- holder with preattached multiple sample adapter is a sterile, non-invasive device used to connect devices with male or female luer connectors to blood collection tubes for the collection of blood.

The proposed devices are blood collection devices form a channel between patient's vein and the evacuated blood collection tube intended for collection of blood. The Blood Collection Needle with/without Holder is intended for single use only, which consists of a non-patient needle cap or holder, non-patient needle, rubber sleeve, patient needle cap, patient needle, hub. They are available in different configurations. The Safety Blood Collection Needle with/without Holder is intended for single use only, which consists of a non-patient needle cap or holder, non-patient needle, rubber sleeve, patient needle cap, patient needle, hub, safety shield. They are available in different configurations. The safety shield will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. In addition, the proposed devices are available in different specifications of needle gauge(27G-18G) and length (1"-1.5"). The Luer Access Device- holder with Pre-attached Multiple Sample Adapter is intended for single use only, which consists of a holder, non-patient needle, rubber sleeve, and a male (or female) luer lock hub which mates the female (or male) connector of other medical devices. The luer hub is permanent assembled with holder. It can be used to establish a channel to connect with medical vacuum tubes and transfer fluids.