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510(k) Data Aggregation
K Number
K111517Device Name
PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI
Manufacturer
PHARMAJET, INC.
Date Cleared
2011-07-27
(55 days)
Product Code
KZE
Regulation Number
880.5430Why did this record match?
Applicant Name (Manufacturer) :
PHARMAJET, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
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.
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K Number
K110456Device Name
PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
Manufacturer
PHARMAJET, INC.
Date Cleared
2011-03-02
(14 days)
Product Code
KZE
Regulation Number
880.5430Why did this record match?
Applicant Name (Manufacturer) :
PHARMAJET, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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.
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K Number
K081532Device Name
PHARMAJET NEEDLE-FREE INJECTION SYSTEM
Manufacturer
PHARMAJET, INC.
Date Cleared
2009-02-26
(269 days)
Product Code
KZE
Regulation Number
880.5430Why did this record match?
Applicant Name (Manufacturer) :
PHARMAJET, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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.
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