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510(k) Data Aggregation
K Number
K091200Device Name
XTRACT SYRINGE KEYS
Manufacturer
Date Cleared
2009-08-21
(119 days)
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
XTRACT SOLUTIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The XTRACT Solutions Syringe Keys are indicated as accessories for specified commercially available piston hypodermic syringes (for medical purposes) and designed to control the distance the syringe plunger can be drawn through the syringe barrel and to facilitate the user in obtaining accurate, consistent and precise volumetric draws from vials containing liquids such as vaccinations, allergenic extracts and medications. The XTRACT Solutions Syringe Keys are designed and should be used only with the Terumo SurSaver Mixing Syringes (product code SS01A2313T) and/or the Greer Optimix (GROM-23) SurSaver Mixing Syringes,
Device Description
The XTRACT Syringe Key is a hand held passive tool and an accessory designed to conveniently and ergonomically fit between the plunger thumb rest and the finger grip of piston hypodermic syringes. Designed to fit the Terumo SurSaver and Greer Optimix (GROM-23) Mixing Syringes, the XTRACT Syringe System facilitates the user in obtaining rapid, accurate and precise volumetric draws from vials containing vaccines, allergenic extracts and medications. The Syringe Key Set contains eight (8) individual Syringe Keys which are attached together by a stainless steel round-bead chain. A set contains keys for the following volumetric draws: 0.05 mL, 0.10 mL, 0.15 mL, 0.20 mL, 0.25 mL, 0.30 mL, 0.50 mL, 1.00 mL. Channels in both surfaces of the Key run along the width from edge to edge. The syringe plunger's thumb rest is inserted at one edge of the channel, the plunger is pulled from the syringe barrel as it is placed in the channel and the finger rest of the syringe barrel is located on the opposite channel edge. Materials used to fabricate the XTRACT Syringe Keys are polymers that have a long use in medical devices such as white delrin (polyoxymethylene) and polyethylene.
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