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510(k) Data Aggregation
K Number
K122837Device Name
AUTOJECT 2 FOR GLASSY SYRINGE
Manufacturer
OWEN MUMFORD, LTD.
Date Cleared
2012-10-15
(28 days)
Product Code
KZH
Regulation Number
880.6920Why did this record match?
Applicant Name (Manufacturer) :
OWEN MUMFORD, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Autoject® II for glass syringe is a non-sterile fully automatic injection device. The device is intended for the self-administration of an FDA approved drug. The device is designed for use with 1ml fixed needle pre-filled glass syringe, for use in the home to aid, support and reduce patient liked needle phobia. It has been developed to provide a safe and simple procedure to the patient.
Device Description
The 'Autoject® II for glass syringe' is composed of simple plastic injection moulded parts and stainless steel springs. The device is a non-sterile, handheld mechanical device intended for self-administered, subcutaneous delivery of an FDA approved drug. The device is designed for use with 1ml fixed needle pre-filled glass syringe, for use in the home to aid, support and reduce patient liked needle phobia. It has been developed to provide a safe and simple procedure to the patient.
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K Number
K011951Device Name
EZ SYRINGE
Manufacturer
OWEN MUMFORD, LTD.
Date Cleared
2001-08-02
(42 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
OWEN MUMFORD, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The hand held device is intended to aid in the self-administration of drugs from a prefilled BD Hypak 1 ml disposable glass syringe. The device incorporates enlarged wings to facilitate gripping and a semi-automatic feature to remove the needle shield of the Hypak syringe.
Device Description
The EZ Syringe O.T.C is a hand held, non-sterile manual device using 1 ml BD Hypak disposable glass pre-filled syringe. The devices are designed for use with the 1 ml BD Hypak disposable glass syringe, and to accommodate self- use in the home by the patient or caregiver. The device incorporates enlarged wings to facilitate gripping and a semi-automatic feature to remove the needle shield of the Hypak syringe. The device contains a number of features which adds to its safety and effectiveness, these are as follows :- - Parking Action of Boot Remover. - Drop Test. - Environmental .
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K Number
K000482Device Name
MODIFICATION TO AUTOJECT MINI
Manufacturer
OWEN MUMFORD, LTD.
Date Cleared
2000-03-06
(21 days)
Product Code
KZH
Regulation Number
880.6920Why did this record match?
Applicant Name (Manufacturer) :
OWEN MUMFORD, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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