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Insulin syringes are intended for subcutaneous injection of U-100 insulin

The insulin syringe consists of needle cap, barrel, plunger stopper, needle tube and plunger cap. It is sterile disposable, non-pyrogenic, easy to use and meets all of the required standards. The plunger cap is optional. The single insulin syringe in unit package lacks the plunger cap compared with the product in the multi-unit package. The needle cap is used to protect physical protection of the needle prior to use. The needle tube penetrates the patient's skin to inject fluid into the body. The plunger stopper is the sealing assembly that encloses mandrel component and is used to inject fluid into the body. The barrel is a tube-like and cylindrical structure that holds insulin before the injection. The plunger is the rod pushed down or up depending on clinical use. The plunger cap is used to protect plunger before use. The capacity of the insulin device is 0.3 mL, 0.5 mL and 1 mL. The specification of needle tube is 26G, 27G, 28G, 29G, 30G, 31G, 32G and 33G. The needle length is 5 mm, 6 mm, 8 mm and 10 mm.

The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. The intended user population of insulin pen needle is for "Adult Use Only" (ages 21yrs old and above).

The proposed device, Insulin pen needle and insulin injection pen are use cooperatively to inject insulin into the human body. The Insulin Pen Needle is composed of a needle container, a needle shield, a needle hub, a needle tube. The insulin pen needle for single use is offered in various gauge sized and length. The proposed device is available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 106.

The Blood Collection Needle (with/without Needle Holder) is intended to be used with a vacuum blood collection tube for the collection of venous blood.

The subject devices are blood collection devices used in routine venipuncture procedures, which form a channel between the patient's vein and the evacuated blood collection tube intended to collect blood. The Blood Collection Needle (with/without Needle Holder) is intended for single use only and consists of a bottom sheath or needle holder, needle tube, rubber cap, upper sheath, and hub. They are available in different configurations. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions. It is manufactured from tubular stainless steel sharpened at both ends and is attached to the hub: - -The subject devices are available with a pre-attached needle holder or without a needle holder; the hub is threaded on one side to connect with the needle holder, which is used to guide the needle into an evacuated blood collection tube. This needle's end is shorter and fitted with a protective rubber cap and a needle holder. - The opposite end of the needle is longer for withdrawing blood and is fitted with a needle sheath. The subject devices are available in different specifications of needle gauge (25G-18G) and length (3/4"-1 1/2"). The proposed devices are only packaged as sterile, disposable, and single-patient use. The devices are packaged for sterile, single-use, and single-patient use only.

The safety blood collection needle without a needle holder is intended to be used with a vacuum blood collection tube to collect venous blood. The safety shield is intended to protect against accidental needle stick injury.

The proposed device is a blood collection device to form a channel between the patient's vein and the evacuated blood collection tube intended for blood collection. The Pipe pluq piercing needle is designed with a rubber cap, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needle stick injury. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions. The Safety blood collection needles without needle holders are manufactured from tubular stainless steel sharpened at both ends that are attached as follows: - -The threaded hub has one side that is to connect with the needle holder, which is used to guide the needle into a vacuum blood collection tube. This end of the needle is shorter and fitted with a rubber cap and a needle hub. - -The opposite end of the needle tube is 3/4"-1 1/2" for blood collection and is fitted with a protective sleeve. The needle hub and protective cap protect the needle tube. The safety feature is easily operated through the release of a latch mechanism whereby the user slides a safety shield over the needle as it is removed from the patient. Once the needle is covered, the safety shield locks in place. This mechanism is substantially equivalent to that of the predicate device. The devices are packaged as sterile, single-use, and single-patient use only. The proposed device is comprised of the components listed below: - 1. Bottom sheath - 2. Rubber cap - 3. Needle hub - 4. Connecting base - 5. Safety shield - 6. Needle tube - 7. Upper sheath

Safety blood collection needles with/without needle holder are intended to be used with vacuum blood collection tubes for multiple collections of venous blood. The safety shield is intended to aid in the protection against, accidental needle stick injuries.

The Safety blood collection needles with/without needle holder is used in routine venipuncture procedures. That is composed of a bottom sheath, rubber cap, needle hub, connecting base, safety shield, needle tube, upper sheath, and optional needle holder, which are made from PP, PE, ABS, rubber, and SUS materials. The proposed device has various configurations and sizes, differing in various colors for easy recognition by use. The threaded hub is one side that connects with the needle holder, which is used to quide the needle into a vacuum blood collection tube. This end of the needle is shorter and is fitted with a rubber cap and a needle hub. The Safety blood collection needles with /without needle holder are manufactured from tubular stainless steel sharpened at both ends that are attached: - The opposite end of the needle tube is ¾" ~ 1 ½″ for blood collection and is fitted with a protective sleeve. - The needle hub and protective cap protect the needle tube. The self-locking mechanism is positioned within the center and the proximal end of the sheath. The hinge structure could let clinical personnel flexibly adjust the sheath to the designed position for use. The safety feature is easily operated by releasing a latch mechanism whereby the user slides a safety shield over the needle as it is removed from the patient. Once the needle is covered, the safety shield locks in place.

The LDV (Low Dead Volume) Syringe is intended to be used for medical purpose to inject fluid into or withdraw fluid from body.

The LDV (Low Dead Volume) Syringe is consistent with the calibrated syringe and permanent needle intended to be used for injection or withdrawal of fluids to or from the human body. The needle is fixed that cannot be removed. The needle cap is colored to differentiate the different types of needle models. The syringe plunger is well-designed to reduce the fluid waste, called low dead volume or low dead space. The LDV (Low Dead Volume) Syringe has various colors, syringe volumes, needle gauge sizes, and needle length sizes, which could be applied in different clinic-use scenarios. Meanwhile, the device is sterilized with ethylene oxide and without any pyrogen. Therefore, this is a single-use device that should be immediately discarded after use.

The Safety Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury. The Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.

The Blood Collection / Infusion Set (with/without needle holder) is a single-use, sterile, winged needle bonded to flexible tubing with a Luer connector. The Blood Collection / Infusion Set (with/without a needle holder) is individually wrapped and sterile with a luer port. The luer port can connect FDA cleared accessories like luer adapter, holder, etc. The Safety Blood Collection / Infusion Set (with/without needle holder) is a single-use, sterile, winged needle bonded to flexible tubing with a Luer connector and a safety mechanism. The winged needle is designed with a safety mechanism, which allows for activation, ensuring the needle is covered immediately following venipuncture to protect against accidental needlestick injury. The Safety Blood Collection / Infusion Set (with/without a needle holder) is individually wrapped and sterile with a luer port. The luer port can connect FDA cleared accessories like luer adapter, holder, etc. The safety feature is easily operated by releasing a latch mechanism whereby the user slides a winged cover over the needle removed from the patient. Once the needle is covered, the safety cover locks in place. There is no ability to clean and reuse these devices because the safety feature cannot be deactivated without bending the needle and rendering it unusable. The Blood Collection / Infusion Set (with/without needle holder) and Safety Blood Collection / Infusion Set (with/without needle holder) are used for venous blood collection and/or the short-term infusion of intravenous fluids. It can be used with an intravascular administration set or a syringe or other device to administer fluids. The product is to be used by appropriately trained healthcare professionals only in accordance with the manufacturer's instructions.

The Safety Blood Collection Sets for Single Use and blood collection tube/syringe are used together for the collection of venous blood. The winged needle is designed with a safety shield to cover the needle immediately following blood collection to aid in the protection against accidental needlestick injury.

The Safety Blood Collection Sets for Single Use are used in routine venipuncture procedures. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately the following venipuncture to aid in the protection against accidental needlestick injury. The Safety Blood Collect Sets is compatible for use with a tube and syringe. The product is to be used by appropriately trained healthcare professionals, only following the product instructions. The Blood Collection needle is manufactured from tubular stainless steel sharpened at both ends that is attached to the hub. The hub is threaded on one side to connect to the needle holder, which is used to guide the needle into an evacuated blood collection tube. This end of the needle is the shorter end and is fitted with a protective rubber cap and a needle holder. The opposite end of the needle is 3/4" long for withdrawing blood and is fitted with a needle sheath. The needle holder and needle sheath protect the needle. The safety feature is operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks in place. This mechanism is substantially equivalent to the predicate device. The proposed devices are packaged as sterile, single-use, and single patient use only. The proposed device consists of ten components: 1. needle holder 2. rubber sleeve 3. puncture needle 4. needle hub (male luer lock connector) 5. connect base (female luer lock connector) 6. flexing tube 7. safety shield 8. wings 9. patient-end tube needle 10. needle sheath

Hypodermic Safety Needle with Syringe: The Hypodermic Safety Needle with Syringe is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. Hypodermic Safety Needle: The Hypodermic Safety Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

The device is used for subcutaneous injection, intravenous injection of blood and preparation of liquid medicine. The needle tube will be pushed into safety cap after use. It is designed to aid in the prevention of needle stick injuries. This device is a single use device, which is delievered sterile. The device is a disposable anti-needle stick syringe made of the following components: Needle cap, Needle tube, Safety shield, Needle hub, Barrel, Plunger, Plunger stopper.