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510(k) Data Aggregation

    K Number
    K112936
    Device Name
    SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM
    Manufacturer
    REXAM CONSUMMER PLASTICS INC.D/B/A REXAM PHARMA
    Date Cleared
    2012-01-20

    (109 days)

    Product Code
    MEG
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    D/B/A REXAM PHARMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single use devices that are indicated for use as an accessory with BD Hypak Sterile Clean Fill (SCF) glass Prefilled Syringes 1 mL long to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist self-injecting patients, from accidental needlesticks. The devices can be used on a wide range of patients including children and adults.
    Device Description
    The Safe'n'Sound® Luer Lock Passive Delivery System is an anti-needlestick accessory for use with BD Hypak SCF glass Prefilled Syringes. It fits with needles 1" long maximum, and consists of a body assembly and a loose plunger rod.
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    K Number
    K101233
    Device Name
    SAFE'N'SOUND PASSIVE DELIVERY SYSTEM
    Manufacturer
    REXAM PHARMA
    Date Cleared
    2011-02-18

    (291 days)

    Product Code
    MEG
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    REXAM PHARMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single use devices that are indicated for use as an accessory with sterile 1 mL long staked needle prefilled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist self-injecting patients, from accidental needlesticks. The devices can be used on a wide range of patients including children and adults.
    Device Description
    The Safe'n'Sound Passive Delivery System is an antineedlestick accessory for use with sterile prefilled ISO Standard glass syringes. It fits 1 mL long staked needle syringes, and consists of a body assembly and a loose plunger rod.
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