PharmaJet's STRATIS® needle-free injector has received FDA 510(k) marketing clearance for 0.5mL intramuscular and subcutaneous injections of liquid vaccines and medicines. This FDA marketing clearance (#K111517) specifies the following Indications for Use:
“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.”
FDA’s regulation 21 CFR 880.5430, specifically states that such devices “may be used for mass inoculations.”
Refer to the STRATIS® Jet Injector Instructions for Use and the individual device and vaccine labeling to ensure safe injections and to review risks. For further information please contact PharmaJet Regulatory Affairs at 303.526.4278.
According to the Centers for Disease Control and Prevention (CDC) General Recommendations on Immunizations - 2011
“Jet injectors prevent needle-stick injuries to health-care providers and can overcome improper, unsterile reuse and other drawbacks of needles and syringes in developing countries. Immune responses generated by jet injectors against both attenuated and inactivated viral and bacterial antigens are usually equivalent to, and occasionally greater than, immune responses induced by needle injection.”
Ref: 2011 CDC General Recommendations on Immunizations
About PharmaJet Inc. and Needle-free Injection Technology:
PharmaJet’s needle-free injection technology delivers liquid drugs and vaccines to intramuscular, subcutaneous and intradermal tissue depths. PharmaJet injectors create a fine stream of liquid that penetrates the skin, delivering doses to the desired depth, while eliminating needle-stick injuries, needle reuse and the burden of sharps waste management. For additional information on PharmaJet and Needle-free technology, please visit www.pharmajet.com.