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510(k) Data Aggregation
K Number
K020786Device Name
INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM
Manufacturer
Date Cleared
2002-09-25
(198 days)
Product Code
Regulation Number
880.5430Why did this record match?
Applicant Name (Manufacturer) :
ROSCH AG MEDIZINTECHNIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The INJEX ™- and ROJEX ™ needle- free Injection System Extra is exclusively designed to deliver medicines that can be administrated subcutaneously by jet injection propelling a jet of liquid medicine through the skin into subcutaneous tissue under high pressure.
This medical device is intended for the application of prescription drugs and to sale by or on the order of a physician.
Target Population: Patients who have to be injected with liquid pharmaceuticals.
Device Description
The INJEX™ and ROJEX™ Systems Extra are medical devices to apply liquid medicine needle-free through the skin into the subcutaneous tissue. The process is based on the generation of a defined high velocity jet of fluid to penetrate the skin and to transport the medicine to the subcutaneous tissue. The energy source to accelerate the fluid within the ampoule is an internal spring.
The INJEX™ Injector is designed for multi- use. To tense the spring within the small hand- held injector for injection the reset box is used. For patient's safety the injector is equipped with two safety mechanisms. The automatic mechanism will be deactivated by mounting the ampoule onto the injector, and before injecting
The ROJEX™ Injector is a disposable medical device for single- use. For patient's safety the injector is equipped with a manual safety mechanism, the safety ring. Before injecting the dose of medicine to the individual the safety ring needs to be shifted into the safe- off position.
To transfer the medicine from its different repositories into the ampoule several adapters are designed. In case, medicines in cartridges are used an aid is available: the transporter.
The INJEX™ Systems Extra consist of two main components which are re- usable:
- . INJEX™ Injector
- . Reset Box
The ROJEX™ Systems Extra represent the disposable medical device:
- · ROJEX™ Injector, pre- tensed
The three accessories for INJEX™ needle- free Injection systems Extra are:
- Transporter, re- usable .
- Adapter, sterile, usable for one medicine repository .
- Ampoule, sterile, for single- use .
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