Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K060672
    Device Name
    ONE STICK Y EXTENSION SET AND VOLUMETER
    Manufacturer
    Date Cleared
    2006-03-31

    (17 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    ONE STICK LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    FOR 7th Collections AND Ax بي جي جي هم INDICATED OF White -17-11-17 Blours SPECIMIANS Priva 70 FURTHER TESTING The One Stick™ Volumeters™ and Y-Set families are indicated for the collection and handling of blood specimens prior to further testing.
    Device Description
    One Stick" Volumeters™ and Y-Set family of sets are supplied as sterile devices, and are intended for single patient use only. They are available in 3cc and 5cc sizes and are manufactured per cGMP Standards. The Y sets are comprised of standard components currently on the market. The Y sets are currently covered by 510(k) K051499. The barrel of the Volumeter™ is currently marketed by Becton Dickinson in their 3ml syringe. The Vent cap is molded with Class VI polypropylene, silicone O-ring and a Gore expanded PTFE supported membrane. The One Stick™ Device is a blood collection assistance device for drawing samples from patients with suboptimal blood flow for standard procedures (Elderly and pediatric patients, those patients that may experience blood vessel collapse or excessive hemolysis when conventional Vacutainers are used directly). The device consists of a male luer fitting for attaching to a venipuncture, a section of tubing connecting the luer to a Y-Connector with a Roberts clamp for interrupting flow, two additional sections of tubing attached to needless access devices. This Y device is then attached to a vented volume collection tube.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1