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The Biojector® 2000 is indicated for delivery of subcutaneous (SC), intramuscular (IM) or intradermal (ID) injections of vaccines and other pharmaceutical injectables. The Biojector® 2000 may be used by healthcare providers who routinely administer injections. The Biojector® 2000 may also be used by patients authorized by their healthcare practitioner to self inject, or have other individuals administer injections of prescribed medication. The addition of the intradermal indication is facilitated by using the new Intradermal Spacer with a No. 2 Syringe. Intradermal injections of vaccines and other pharmaceuticals are performed on the same patient populations that are now being treated with the Biojector® 2000 for the previously cleared indications.

The Bioject® 2000 Needle-Free Injection Management System is designed to deliver vaccines and other pharmaceutical injectables by producing a high pressure injectate stream that penetrates the dermis. The system is composed of three major components: (1) the injector -Biojector® 2000; (2) sterile single use disposables - syringes in multiple orifice sizes, safety cap, filling adapter and intradermal spacer (packaged for use with a No. 2 syringe only); and (3) power source - carbon dioxide (CO2) cartridge or tank. The depth of injectate penetration is dependant upon the svringe orifice diameter. In general. the larger the diameter of the syringe orifice, the deeper into the tissue the fluid will be deposited. Disposable syringes with a variable volume from 0.1 ml to 1 ml are numbered 2, 3, 4, 5 and 7, and have increasing syringe orifice diameters, 0.04", 0.08", 0.10" and 0.14" respectively. Intradermal injections (ID) are only performed using a No. 2 syringe (the smallest diameter) and an ID Spacer. As the distance from the syringe orifice to the skin is increased, the energy density of the fluid stream is decreased. The ID Spacer utilizes this principle to provide the optimum distance from the syringe to the skin to provide enough energy for the injectate to penetrate the epidermis, but not enough energy to transverse the underlying dermal tissue Subcutaneous (SC) injections are performed using a No. 2 syringe that is in direct contact with the skin, no spacer is utilized. Intramuscular (IM) injections are performed using syringes in contact with the skin and with larger orifice diameters. The disposable syringe assemblies are provided sterile in a Tyvek blister peel pouch. The ID Spacer is manufactured from a high density polyethylene that meets the same environmental, biocompatibility and sterility requirements as the disposable syringes. The ID Spacer is packaged as a component with Biojector® No. 2 syringe assemblies.

The PharmaJet® Stratis Needle-free Injection System is intended to deliver various medications and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine to the body. Healthcare providers who routinely administer injections may use the PharmaJet® Needle-free Injection System. It may be used for adults and children. It can also be used by patients authorized by their physicians to self-inject, or to have other individuals administer injections of prescribed medication.

The PharmaJet® Stratis 0.5 mL Needle-free Injection System is a compact, spring-loaded needle-free hypodermic injection system. The PharmaJet® System consists of an injector, a reset station, a single use, sterile disposable filling adapter, and a single use, sterile, disposable needle-free syringe. The components of the system may be sold separately for replacements as they are used. The components of the PharmaJet® System are unique and cannot be used with any other needle-free system.

The PharmaJet Needle-free Injection System is intended to deliver various medications and vaccines intradermally by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine into the dermis. Healthcare providers who routinely administer injections may use the PharmaJet Needle-free Injection System. It may also be used by patients authorized by their physicians to self-inject, or have other individuals administer injections of prescribed medication.

The PharmaJet 0.1 ml Needle-free Iniection System (PharmaJet Svstem) is a compact, spring-loaded needle-free hypodermic injection system. The PharmaJet System consists of an injector; a reset station; a single use, sterile disposable filling adapter; and, a single use, sterile, disposable needle-free syringe. The components of the system may be sold separately for replacements as they are used. The components of the PharmaJet System are unique and cannot be used with any other needle-free system. An injector is placed in the reset station and the lid is depressed to reset the spring in the injector. A health care worker puts a filling adapter into a vial of liquid medicine or vaccine. A Needle-free syringe is placed into the filling adapter, the liquid is drawn into the Needle-free syringe and is slightly over filled. The filled Needle-free syringe is removed from the adapter and the plunger is broken off and discarded. The Needle-free syringe is placed into the injector with a ¼ turn to the right, which positions the plunger so that a 0.1ml dose is ready for use. The Needle-free syringe is placed against the injection site; gentle pressure is applied until the inner housing stops. This action allows the trigger to be released. By depressing the trigger the spring is released and the plunger moves forward into the needle-free syringe barrel discharging the contents. Once the injection has been performed, the Needle-free syringe is properly disposed of and a new syringe may be filled, injector reset, and the system again prepped for use.

The LectraJet Needle-Free Injection System is intended to deliver subcutaneous (SQ) or intramuscular (IM) injections of vaccines and other injectable medications. The LectraJet Needle-Free Injection System may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections. The LectraJet Needle-Free Injection System may also be used by patients to self inject or to have other individuals administer injections of prescribed medications.

The components of the LectraJet® Needle-Free Injection System include the needle-free single-use syringes with disposable vial adapter and cap with plunger rod attached and the injector handpiece with manual reset mechanism. The LectraJet® handpiece and reset mechanism are sold as a complete injection system contained within a carrying case. The carrying case is an accessory of convenience that provides for portability, organization, and ease of use for the practitioner. The LectraJet® syringes are packaged sterile and designed to be filled by the end user at the time of use. The polycarbonate syringes have a molded orifice at the front end. The syringe orifice is available in sizes 0.006", 0.008", 0.010" and 0.012" diameter, which allows the user to choose the syringe appropriate for the desired depth of penetration (IM/SQ) and patient selection (child/adult). The syringes have a flange at the back end that is held by the injector handpiece when delivering the injection. Syringes are designed to be used immediately upon filling, similar to a traditional needle and syringe, and identical to the Biojector 2000® and Medi-Jector Vision® syringe filling philosophy. After the syringes are filled, they are inserted directly into the LectraJet® handpiece. The LectraJet® handpiece contains a spring drive system that, when compressed, provides the energy to deliver the injection. To compress the spring, the handpiece is placed in a manual reset mechanism and hand pressure is applied to the reset mechanism lever. In the Medi-Jector Vision®, the manual power source used to compress the spring is a hand-twist knob. In the Biojector 2000®, the power source is either a gas cartridge or a gas cylinder. When the LectraJet® handpiece is actuated, the spring drive system is released, and the handpiece ram contacts the syringe piston to drive the injectate out through the syringe orifice, creating a jet stream with enough energy to penetrate the tissue. This is identical in principle to the Biojector 2000® and the spring powered Medi-Jector Vision®. After the injection, the used syringe is released into an appropriate trash container. Little maintenance is required for the LectraJet® handpiece. There are no o-rings or seals to change. No sterilization of the handpiece is required. All of the above features are similar to the Biojector 2000® and the Medi-Jector Vision®, predicate devices and accessories.

The Zetajet is indicated for delivery of subcutaneous or intramuscular injections of vaccines and other injectable drugs into standard injection sites. The Zetajet may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections. The Zetajet may also be used by patients authorized by their physicians to self inject, or have other individuals administer injections of prescribed medication.

The Zetajet Needle-free Injection Therapy System is a compact, spring-powered, needlefree delivery system. It is intended to deliver vaccines and injectable medications either subcutaneously or intramuscularly. The Zetajet system consists of the injector body and the single-use, sterile syringe assembly with a pre-inserted piston in the syringe. The Zetajet uses jet force to propel a finely dispersed stream of the injectable medication into the subcutaneous or intramuscular tissue. The disposable assembly consists of a single-use, sterile, disposable syringe designed to contain a volume between 0.05 and 0.5 ml and a plunger to discharge the medicine or vaccine through a syringe orifice size based on the type of injection to be given (either subcutaneous or intramuscular).

The PharmaJet Needle-free Injection System is intended to deliver various medications and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine to the body. Healthcare providers who routinely administer injections may use the PharmaJet Needle-free Injection System. It may be used for adults and children. It can also be used by patients authorized by their physicians to self inject, or have other individuals administer injections of prescribed medication.

The PharmaJet, Inc. PharmaJet Needle-free Injector System (PharmaJet System) is a compact, spring-loaded needle-free hypodermic injector system. The PharmaJet System consists of two (2) injectors (One is the light injector suitable for infants up to two years old, geriatric adults or locations with thin skin and minimal adipose tissue and one is the heavy injector suitable for adults and children two years and older, or locations with thicker skin and more adipose tissue.), a cocking device, a single use, sterile, disposable filling adapter, and a single use, sterile, disposable needle-free syringe.

The Airgent™ System is a needle-free injection system designed for the administration of various medicines and vaccines to the body by means of a high velocity jet of fluid that penetrates the skin. The Airgent™ includes a disposable delivery kit intended for multiple injections on a single patient. The Airgent™ System is indicated for professional use only.

The Airgent" System is an automated, multi-use, needless injector system, intended to deliver medications and vaccines to the body by a highly accelerated pneumatically powered jet of fluid via a very small entry point in the surface of the skin The system is comprised of a console and single-use sterile injector kit The user may control the dosage (150ul/200ul) and system pressure for the injection via the graphical user interface on the front panel of the console The entire injector kit is replaced between patients and may be used for multiple injections per patient

The cool.click 2™ Needle-free Growth Hormone Delivery System is indicated for the administration of Serono's growth hormone drug products and is intended for home use by patients authorized by their physicians to self-inject.

cool.click 2™ is a needle-free delivery device for Serono growth hormone products. The device delivers the drug product by firing a jet of liquid directly through the skin to the subcutaneous region. The jet is created via a powerful spring acting on a piston inside the nozzle and the liquid is forced out through a small aperture at high speed, creating a very fine, high pressure stream of drug that penetrates the skin. The key difference of the cool.click 2™ Needle-Free Growth Hormone Delivery System is it has a digital display to provide more clear and accurate information to users.

The Mini-Ject device is a needle-free injection system designed to deliver fluid subcutaneously. This nonelectrically powered device is intended to deliver an injection of fluid by means of a high velocity jet of fluid that penetrates the skin and delivers the fluid to the subcutaneous area of the body. The Mini-Ject device is intended for home and professional use. It may be used by physicians, nurses and other practitioners who routinely administer injections and by patient authorized by their physicians to self inject at home.

The Mini-Ject device is a needle-free injection system designed to deliver fluid subcutaneously. This nonelectrically powered device is intended to deliver an injection of fluid by means of a high velocity jet of fluid that penetrates the skin and delivers the fluid to the subcutaneous area of the body.

This product is indicated for Needle-Free Self Injection of Saizen® [somatotropin (rDNA origin) for the replacement of endogenous growth hormone in adults with growth hormone deficiency.

Needle-Free Self Injection Device for Personal Use with Saizen® [somatropin (rDNA origin) for injection]. Needle-Free Injector, Jet Injector