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510(k) Data Aggregation
K Number
K013362Device Name
AUTOJECT 2
Manufacturer
OWEN MUMFORD USA, INC.
Date Cleared
2001-11-13
(34 days)
Product Code
KZH
Regulation Number
880.6920Why did this record match?
Applicant Name (Manufacturer) :
OWEN MUMFORD USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Autoject 2 is a hand held mechanical device intended for a self-administered automated subcutaneous injection of FDA approved drugs. The device is designed for use with a 1ml glass fixed needle syringe, for use in the home by the patient or care-giver to aid and support a recommended treatment regime.
Device Description
The Autoject 2 O.T.C is a hand held non-sterile semi-automatic device using pre-filled 1ml glass syringes capable of a subcutaneous injection of FDA approved drugs. The devices are designed for re-usable use to aid and support patient/ care-giver use in the home with a treatment regime.
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K Number
K993385Device Name
AUTOJET 2 (NON-FIXED NEEDLE TYPE)
Manufacturer
Owen Mumford USA, Inc.
Date Cleared
1999-11-10
(33 days)
Product Code
KZH
Regulation Number
880.6920Why did this record match?
Applicant Name (Manufacturer) :
Owen Mumford USA, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A general purpose hand-held mechanical device intended for the subcutaneous injection of Insulin and other approved drugs. The device is designed for use with disposable 1ml non-fixed needle syringe and to accommodate self use in the home by the patient in order to aid and support compliance with the recommended treatment regime.
Device Description
A hand-held general purpose mechanical injection device for the sub-cutaneous injection of Insulin and other approved medicines.
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K Number
K983994Device Name
UNIFINE
Manufacturer
Owen Mumford USA, Inc.
Date Cleared
1999-01-08
(60 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Owen Mumford USA, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is for the subcuraneous injection of insulin.
The Unifine range of Syringes is designed for the subcutaneous injection of insulin.
Device Description
The Unifica range if syringes are ldentical to that of the Orientan range of syringss manufactured by B Braun. The syringes are manufactured, packed and mentised by B Braun and supplied to Owen Mumford for sale or distribution. No re-packaging roworking or modifications are made to the systems or packaging by Owen Mumford, The are supplied in three sizes (0.3ml, 0.5ml) in boxes of 100. The individual syringes are supplied in peel pouches and are sterilised using Ethylone Oxide.
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K Number
K983974Device Name
OWEN MUMFORD 3ML AUTOPEN
Manufacturer
Owen Mumford USA, Inc.
Date Cleared
1998-12-21
(42 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Owen Mumford USA, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The delivery of insulin products using a variable dose pen for insulin dependent diabetics. The Owen Mumford 3ml Autopen is a non-sterile automatic subcutaneous injection device which uses a replaceable 3ml insulin cartridge Suboutineous injoction in automatic drive system is used to displace the insulin from the cartridge through a sterile disposable needle.
Device Description
Autopen® is cylindrical in shape, approximately 165mm x 15mm including cover. The Owen Mumford 3ml Autopen® is based upon a proven design marketed in both Europe since 1988 and the United Sates since 1989 when 510(k) approval was granted for the Owen Mumford 1.5ml Autopen® K895890. There has been no change at all to the design concept since then, and only minor design improvements otherwise in response to customer feedback and continuous improvement as required of a company with ISO 9001, FDA GMP and EN 46001 status. These changes are essentially cosmetic such as: A) A one piece cap instead of a three piece cap to facilitate assembly. B) The cartridge housing was modified to a one piece rather than a two piece to improve durability. C) The cartridge housing can now accommodate a 3.0ml cartridge as opposed to the 1.5ml and is made of one piece rather than 2 separate components in the Owen Mumford 1.5ml Autopen® K895890. D) The printing on the dose selector was changed to improve visibility. The Owen Mumford Autopen® 3ml is a non-sterile, automatic, subcutaneous injection device which uses a replaceable 3ml insulin cartridge (supplied by others) held within the body of the device. Maximum delivery is 42 units in 2 unit increments. An automatic drive system is used to displace the insulin from the cartridge through sterile disposable pen needles.
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K Number
K982275Device Name
RAPPORT V.T.D.
Manufacturer
Owen Mumford USA, Inc.
Date Cleared
1998-12-04
(158 days)
Product Code
LKY
Regulation Number
876.5020Why did this record match?
Applicant Name (Manufacturer) :
Owen Mumford USA, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to achieve a penile erection for men suffering from erectile dysfunction.
Device Description
The Rapport VTD is a vacuum therapy impotence management system providing a simple, non-surgical, non-invasive method of creating and maintaining an erection in men with erectile dysfunction. The product consists of a hand pump and penile tube, used to create a vacuum, and loading cones, constriction rings and transfer sleeve used to maintain the erection.
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K Number
K983045Device Name
AMIELLE
Manufacturer
Owen Mumford USA, Inc.
Date Cleared
1998-11-25
(85 days)
Product Code
KXP
Regulation Number
884.3900Why did this record match?
Applicant Name (Manufacturer) :
Owen Mumford USA, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended to treat women suffering from vaginismus and dyspareunia. VAGINISMUS is the involuntary spasm of the muscles in the vaginal wall which then inhibits sexual intercourse by making it painful or impossible. DYSPAREUNIA is the pain experienced during sexual intercourse caused by physical and/or emotional problems. The device comes in varying sizes, the most appropriate is then selected by the physician for use by the patient and the patient's partner as an assistant if appropriate. It is used as a tool to DILATE the vagina in controlled stages.
Device Description
Four smooth, high polished finish, hollow, penile shaped cones which are graduated in size and length. Owen Mumfords Amielle is visually and mechanically similar to that of Young's Vaginal Dilator to which substantially equivalence is claimed.
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K Number
K973899Device Name
UNIFINE PENTIPS
Manufacturer
Owen Mumford USA, Inc.
Date Cleared
1997-12-04
(51 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
Owen Mumford USA, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Unifine Pentip are intended for the subcutaneous injection of drugs from prefilled cartridges used in conjunction with variable dose delivery systems such as Pen Injectors. Its intended use is substantially equivalent to that of the BD Microfine.
The Unifine Pentip is single use, disposable hypodermic single lumen needle designed for use with multidose injection devices that use prefilled cartridges.
The protective paper is removed from the Pentip which is then screwed onto the device cartridge housing and then used in the prescribed manner.
One of the main uses of the Pentip is for use with pen Injectors for the delivery of insulin which is supplied in the form of prefilled cartridges. The patient places a fresh Pentip needle onto the Pen Injector, dials a dose, inserts the Pentip into the skin and delivers the dose.
Device Description
The Owen Mumford Unifine Pentip is visually and mechanically extremely similar to the BD Microfine Pentip to which substantial equivalence is claimed.
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K Number
K971443Device Name
RAPPORT V.T.D.
Manufacturer
OWEN MUMFORD USA, INC.
Date Cleared
1997-09-26
(158 days)
Product Code
LKY
Regulation Number
876.5020Why did this record match?
Applicant Name (Manufacturer) :
OWEN MUMFORD USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to achieve a penile erection for males suffering from erectile dysfunction.
Device Description
The Rapport Vacuum Therapy Device is an impotence management system providing men with erectile dysfunction to create and maintain an erection. The device works on a vacuum principle, creating a negative pressure around the penis thus creating an erection. The device construction is detailed in the section on PRODUCT DESCRIPTION.
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