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510(k) Data Aggregation
K Number
K070100Device Name
HASELMEIER PEN
Manufacturer
Date Cleared
2007-03-21
(70 days)
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
HASELMEIER SARL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Haselmeier Pen is a hand-held mechanical device intended for the subcutaneous, self-administration of FDA-approved drugs and biologics. The Haselmeier Pen is designed to be used with 3.0 mL cartridges which are prefilled prior to an injection. The Haselmeier Pen is for use in the home environment to aid and support prescribed treatment and therapy.
Device Description
The Haselmeier Pen is a self injection device for use as a reusable multiple dose delivery system for subcutaneous injections of FDA-approved drugs and biologics. A cartridge is loaded into the barrel of the pen and a needle attached. The user sets the dose required and delivers the dose by pressing down on the top of the dose button. After injection, the needle is removed from the pen and discarded.
The device is compatible with commercially available pen needles (supplied separately) that comply with: ISO 11608-2 2000 Pen-injectors for medical use - Part 2: Needles - Requirements and test method and 3-ml ISO type A cartridges (supplied separately), which meet ISO 11608-3 2000 Pen-injectors for medical use - Part 3: Finished cartridges - Requirements and test methods, with the following dimensions:
Overall cartridge length including aluminum cap: 63.9 mm ± 0.3 mm
Outside Cartridge Diameter: 11.94 mm MAX.
Inner Cartridge Diameter: 9.65 mm ± 0.1 mm measured at open end.
Maximum eccentricity of aluminum cap: 0.33 mm
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