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510(k) Data Aggregation
K Number
K112475Device Name
XTRACT SYRINGE KEY SYSTEM
Manufacturer
Date Cleared
2011-11-10
(73 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
XTRACT SOLUTIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The product family of Xtract Solutions Syringe Keys are indicated as accessories provided for specified commercially available piston hypodermic syringes (for medical purposes) which are 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 other medications. The Syringe Keys (available for 1mL and/or 3 mL hypodermic syringes) are designed as an accessory only for the following syringes:
1 mL syringes:
. 1 mL Terumo SurSaver Mixing Syringes (SS01A2313T) and/or
. 1 mL Greer Optimix (GROM-23) SurSaver Mixing Syringe.
1.1.2 3 mL syringes:
. 3 mL VanishPoint (RTI10311) Syringes, 23g x 1"
. 3 mL BD SafetyGlide (BD305905) Syringes, 23g x 1" .
. 3 mL BD Integra (BD305271) Syringes 23g x 1"
. 3 mL BD Precision Glide (BD309578) Syringes 20g x 1" .
1.2 The device assists the user in withdrawing precise and accurate liquid volume withdraws from a vial. The Syringe Keys do not facilitate or assist the user with injecting the contents of the hypodermic syringe.
1.3 The Syringe Keys can be used by medical personnel as well as individuals who are not medical professionals; but, have been instructed in their use.
1.4 Syringe Keys will be available for specified piston hypodermic syringe models manufactured by designated syringe manufacturers.
Device Description
The Xtract Solutions 3 mL 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. The 3 mL Syringe Key facilitates the user in obtaining rapid and accurate volumetric with-drawls from vials containing vaccines and other medications. The Syringe Key has been re-designed for ergonomic improvement for the user and to fit four (4) additional piston hypodermic syringes. The 3 mL Syringe Key is 5 inches long and is curved to fit comfortably in the user's hand. At the top of the Key on the underside are three features: Teeth, Groove, and Notch. The plunger is pulled slightly from the syringe barrel and the plunger thumb rest is then nested into a precise slot located at the proximal end of the Syringe Key. After seating the thumb rest in the Syringe Key, the syringe's barrel is moved backward against the proximal flat face of the Syringe Key.
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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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