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510(k) Data Aggregation
K Number
K141384Device Name
WHISPERJECT AUTOINJECTOR
Manufacturer
SCANDINAVIAN HEALTH LIMITED
Date Cleared
2014-09-12
(108 days)
Product Code
KZH
Regulation Number
880.6920Why did this record match?
Applicant Name (Manufacturer) :
SCANDINAVIAN HEALTH LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Whisper JECT autoinjector is a non-sterile injection device. It is intended to be used with FDA approved drug products with non-viscous (aqueous) liquid formulations, which are presented in a BD 1.0 mL pre-filled glass syringe with staked needles. It is a reusable injection device for the subcutaneous injection of FDA approved drugs.
Device Description
The WhisperJECT™ autoinjector is a reusable, spring-loaded injection device that is for general use with 1.0 ml pre-filled glass syringes. WhisperJECTTM autoinjector consists of two subassemblies into which the syringe is loaded and connected together to form the delivery system for self-injection.
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K Number
K124026Device Name
LOBSTER AUTO-INJECTOR
Manufacturer
SCANDINAVIAN HEALTH LIMITED
Date Cleared
2013-09-13
(259 days)
Product Code
KZH
Regulation Number
880.6920Why did this record match?
Applicant Name (Manufacturer) :
SCANDINAVIAN HEALTH LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lobster device is intended for use with a ImL glass syringe, containing a fixed needle of 27G to 29G gauge, and drug product solutions with a viscosity between 1 and 4 mPa*s. The Lobster auto-injector is a reusable injection device for the subcutaneous injection of FDA approved drugs.
For single patient or individual use only.
Device Description
The Lobster Auto-injector is a reusable, spring-loaded injection device that is for use with 1.0 ml pre-filled glass syringes with staked needle. Lobster Auto-injector consists of two subassemblies into which the syringe is loaded and connected together to form the delivery system for self-injection.
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K Number
K120191Device Name
PUSH-ON NEEDLE 30GX8MM
Manufacturer
SCANDINAVIAN HEALTH LIMITED
Date Cleared
2012-05-23
(121 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
SCANDINAVIAN HEALTH LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Push-On Needle is intended for hypodermic injection of fluids into the body when attached to a compatible auto injector.
Device Description
The Push-On Needle is a sterile, non-pyrogenic, single-use, pen needle designed for use with a compatible auto-injector. The Push-On Needle consists of a 30GX 8 mm stainless steel cannula, plastic hub, plastic shield and a protective sealing paper. The assembled Push-On Needle has a circular hub design that clicks and attaches to a cartridge retainer ridge of an auto-injector. Push-On Needle is used by peeling the sealing paper, thus exposing the non-patient end of the needle and pushing this end up against the auto-injector nozzle, and then attaching the needle hub to the auto injector nozzle. The needle shield can be pulled off making the Push-On Needle ready to use.
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