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510(k) Data Aggregation
K Number
K083457Device Name
TACTIPEN
Manufacturer
Date Cleared
2009-02-13
(84 days)
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
HASELMEIER GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TactiPen is a self injection device intended for the subcutaneous injection of U-100 insulin from a 3-mL cartridge.
Device Description
The TactiPen is a reusable pen-injector designed to provide a method of accurately subcutaneously injecting the desired dose of U-100 insulin from a single lumen hypodermic needle. The device can be used by health professionals or for selfinjection by the patient. The pen-injector uses 3.0-mL cartridges of U-100 insulin and a single use, detachable and disposable needle (supplied separately). The pen injector allows the user to dial the desired dose. 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.
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K Number
K082616Device Name
HASELMEIER PEN 8
Manufacturer
Date Cleared
2008-09-26
(17 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
HASELMEIER GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Haselmeier Pen 8 is a hand-held mechanical device intended for subcutaneous selfadministration of FDA-approved drugs and biologics. The Haselmeier Pen 8 is designed to be used with 3.0 mL cartridges which are prefilled prior to injection. The Haselmeier Pen 8 is for use in the home environment to aid and support prescribed treatment and therapy.
Device Description
The Haselmeier Pen 8 is a reusable pen-injector designed to provide a method of accurately subcutaneously injecting the desired dose of medication from single lumen hypodermic needle. The device can be used by health professionals or for selfinjection by the patient.
The pen-injector uses 3.0-mL cartridges of medication and a single use, detachable and disposable needle (supplied separately). The pen injector allows the user to dial the desired dose (0.08 mL).
The device is compatible with commercially available pen needles (supplied separately) that comply with: ISO 11608-2:2000 Pen-injectors for medical use PPart 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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