Search Results
Found 2 results
510(k) Data Aggregation
(154 days)
Profoject™ Insulin Syringes (Model A):
The Profoject™ Insulin Syringes are intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.
Profoject™ Insulin Syringes (Model B):
The Profoject™ Insulin Syringes are intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.
Profoject™ Safelock Disposable Insulin Syringe:
The device is intended for the delivery of U-40 or U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.
Profoject™ Insulin Syringes: Profoject™ Insulin Syringes are categorized into Model A and Model B, the difference is that Model A utilizes an integrated hub and barrel design, and Model B has a separate hub and barrel. The proposed device are 0.3mL, 0.5mL, and 1mL syringes designed for subcutaneous injection of a desired dose of insulin, consisting of needle cap, needle tube, plunger stopper, plunger, barrel and hub (only Model B). Profoject™ Insulin Syringes are sterile, single-use, non-toxic and work on the principle of a piston syringe.
Profoject™ Safelock Disposable Insulin Syringe: The Profoject™ Safelock Disposable Insulin Syringe are 0.3mL, 0.5mL, and 1mL syringes designed for subcutaneous injection of a desired dose of insulin, consisting of needle cap, needle tube, plunger stopper, plunger, barrel, collar and protective shield. The Profoject™ Safelock Disposable Insulin Syringe is a sterile, single-use, non-toxic and work on the principle of a piston syringe.
N/A
Ask a specific question about this device
(168 days)
Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe is used to inject fluids into, or withdraw fluids from, the body.
Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle is used to inject fluids into, or withdraw fluids from, the body.
Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.
Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin. The Sharps Injury Prevention Feature (SIPF) is designed to aid in the prevention of needle stick injuries and syringe reuse.
Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe: Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe consists of a barrel with a Luer Slip or Luer Lock connector which comply with ISO 80369-7, a plunger, and a plunger stopper. The device is available in 0.5 mL and 1 mL capacities. It is sterile, single-use, and non-toxic device that operates on the principle of a piston syringe.
Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle: Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle is sterile, single-use device. Each consists of either a Luer slip or Luer lock syringe assembly integrated with a pre-attached needle, and the syringe is available in two capacities (0.5mL and 1mL). For each capacity variant, the pre-attached needle is available in the following gauge specifications: 16G, 18G, 19G, 21G, 22G, 23G, 25G, 27G and 30G.
Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle: Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle is sterile, single-use, non-toxic devices that work on the principle of a piston syringe, and the syringes are available in three capacities: 0.3mL, 0.5mL, and 1mL. Each capacity variant is equipped with a permanently attached needle, available in the following gauge specifications: 21G, 23G, 25G, 26G, 27G, 28G, 29G, 30G and 31G.
Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe: Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe is sterile, single-use, non-toxic devices that work on the principle of a piston syringe, and the syringes are available in three capacities: 0.3mL, 0.5mL, and 1mL. Each capacity variant is equipped with a permanently attached needle, available in the following gauge specifications: 21G, 23G, 25G, 26G, 27G, 28G, 29G, 30G and 31G.
N/A
Ask a specific question about this device
Page 1 of 1