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It is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood. It is for adult use only.

Blood collection tube holders is single use and sterile, it is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood. It is sterile and to be used for assisting blood collection. The device consists of a puncture needle hub, puncture needle, rubber boot and holder. It is packaged in a sealed sterility barrier. This is a single-use device and delivered sterile. Sterilization process is validated according to EN ISO 11135. Shelf life is 5 years.

The needle is used to access surgically implanted vascular ports. Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only. In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.

Safety Huber Needle is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. The device includes an integrated extension set consisting of a Huber needle and safety mechanism (Type B, Type D and Type E), needle infusion tubing (pressure resistance or non-pressure resistance), Y-injection site, clamp and female Luer lock adapter. The pressure resistance tubing can be used for power injection up to 330 psi. The device will be retained on patient for 24h to 7 days. This submission is new design primarily involve changes to addition of new needle lengths and specifications.

The needle is used to access surgically implanted vascular ports. Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only. In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.

Safety Huber Needle is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention which reduces the risk of accidental needlestick injuries by sheathing the needle. The device includes an integrated extension set consisting of a Huber needle and safety mechanism (Type B, Type D and Type E), needle infusion tubing (pressure resistance or non-pressure resistance), Yinjection site, clamp and female Luer lock adapter. The pressure resistance tubing can be used for power injection up to 330 psi. The device will be retained on patient for 24h to 7 days. This submission is new design primarily involve changes to the type C name, the addition of new needle lengths and new type E.

The safety winged blood collection set is single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The device is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

The Promisemed Safety Blood Collection sets are single-use, sterile, venipuncture needles used for blood collection or short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

It is to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varices and for submucosal dye marking in the GI tract.

It is a flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform needle functions (e.g., injection) during endoscopy. It is designed with appropriate shape, materials and gauge to function through the working channel of an endoscope. This is a single-use device.

Verifine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of drugs.

Verifine® Pen Needles, manufactured by Promisemed Hangzhou Meditech Co., Ltd, are designed for use with pen injectors for the administration of drugs. These are standard pen needles without integrated safety features. The devices are single-use, non-pyrogenic, and maintain a Sterility Assurance Level (SAL) of 10 °. The differences between the PromiseMed current cleared common type needle pen and the new design primarily involve changes to the trade name, the addition of new models, and modifications in some materials and dimensions. Key updates include a change in the trade name, the introduction of new models (FPN and NPN), the addition of new needle sizes and a 5-bevel needle tip option, and a shift from a specific intended use (administering insulin) to a general intended use (administering drugs). The materials used have also been slightly modified, such as changing the needle shield material from polypropylene (PP) to polyethylene (PE) for certain models, which only contact intact skin, ensuring no increased risk. These devices are intended for over-the-counter (OTC) use and require manual insertion by the user during drug administration.

The device is used for endoscopic clip placement within the gastrointestinal(GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3cm, bleeding ulcers, arteries less than 2mm, polyps less than 1.5cm in diameter and diverticula in the colon. Anchoring to affix jejunal feeding tubes to the wall of the small bowel. Closure of Gl tract lumenal perforations less than 20mm that can be treated conservatively.

The Single Use Hemoclip is a sterile, single use device that consists of metal clip that detaches from the introducer to maintain approximation of tissue to achieve hemostasis and endoscopic marking in the gastrointestinal tract. The device is provided sterile (EO). The large clip opening design meets various clinical treatment demands. It can be opened and closed repeatedly and can achieve repositioning. The 360 rotatable design is convenient for clinical use. lt consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.

It is intended to inject fluids into the body or withdraw blood for medical purposes. After injection, the needle tube will be retracted into the barrel when the safety features are manually activated to minimize the risk of accidental sharps injury.

Safety Sterile Syringes is a sterile device consisting of a calibrated barrel, plunger, piston, push button, retraction cylinder, sealing ring, spring and a needle. It is made of plastic, stainless steel and silicone materials. Safety Sterile Syringes have two types: Type F and type D. Type F is a syringe with a fixed needle. Type D is a syringe with a detachable needle. The detachable needle is secured by rotating it through the front needle hub into the back needle hub located on the syringe. Safety Sterile Syringes is using plunger to fill syringe as well as discharge the fluid. After use, by continuing to press the push-button down to depress the plunger all of the way within the barrel, the safety mechanism will be triggered, then the needle tube, needle hub and retraction cylinder will be retracted into the barrel completely under the force of the spring to minimize the risk of accidental sharps injury. Product is delivered sterilization process is validated according to EN ISO 11135. This is a single-use device. Safety Sterile Syringes is intended to be used in professional healthcare facility/hospital and transport environment.

The needle is used to access surgically implanted vascular ports. Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only. In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.

Safety Huber Needle is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needlestick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. The device includes an integrated extension set consisting of a Huber needle and safety mechanism (Type B and Type C), needle infusion tubing (pressure resistance or non-pressure resistance), Y-injection site, clamp and female Luer lock adapter. The pressure resistance tubing can be used for power injection up to 330 psi. The device will be retained on patient for 24h to 7 days.

Insulin Syringe is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.

The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.