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510(k) Data Aggregation

    K Number
    K072037
    Device Name
    CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML
    Date Cleared
    2007-08-08

    (14 days)

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

    LIFE-SHIELD PRODUCTS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CAREO Safety Syringe for U-100 Insulin 0.5cc/mL is a sterile, single-use, disposable and nonreusable, retractable safety syringe which is intended to provide a safe and reliable method for injection of insulin into a patient. The CAREO Safety Syringe for U-100 Insulin 0.5cc/mL is also intended to prevent needlestick injuries. In addition, when the userbreaks the plunger, reuse of the syringe is prevented.
    Device Description
    The Life-Shield Products, Inc., CAREO Safety Syringe for U-100 Insulin 0.5cc/mL is a sterile, single use and disposable, 0.5cc/mL piston syringe, provided with a permanently attached needle in nine product configurations. The CAREO Safety Syringe for U-100 Insulin 0.5cc/mL is similar in appearance, size, materials operation, and purpose to the cited predicate device and other conventional single use, sterile, disposable syringes.
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    K Number
    K061055
    Device Name
    CAREO SAFETY SYRINGE FOR U-100 INSULIN
    Date Cleared
    2006-07-10

    (84 days)

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

    LIFE-SHIELD PRODUCTS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CAREO Safety Syringe for U-100 Insulin is a sterile, single-use, disposable, retractable safety syringe which is intended to provide a safe and reliable method for injection of insulin into a patient. The CAREO Safety Syringe for U-100 Insulin is also intended to prevent needlestick injuries. In addition, when the user breaks the plunger, reuse of the syringe is prevented.
    Device Description
    The Life-Shield Products, Inc., CAREO Safety Syringe for U-100 Insulin is a sterile, single use and disposable, 1cc/mL piston syringe, provided with a permanently attached needle in nine product configurations. The CAREO Safety Syringe for U-100 Insulin is similar in appearance, size, materials operation, and purpose to the cited predicate device and other conventional single use, sterile, disposable syringes.
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    K Number
    K060208
    Device Name
    CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C,
    Date Cleared
    2006-03-10

    (42 days)

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

    LIFE-SHIELD PRODUCTS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CAREO Safety Syringe 1cc/mL is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient. The CARFO Safety Syringe 1cc/mL is also intended to prevent needlestick injuries. In addition, when the user breaks the plunger, reuse of the syringe is prevented.
    Device Description
    The Life-Shield Products, Inc., CAREO Safety Syringe 1cc/mL is a sterile, single use and disposable, 1cc/mL piston syringe, provided with a permanently attached needle in fifteen product configurations. The CAREO Safety Syringe 1cc/mL is similar in appearance, size, materials operation, and purpose to the cited predicate device and other conventional single use, sterile, disposable syringes.
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    K Number
    K052397
    Device Name
    CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML)
    Date Cleared
    2005-12-22

    (113 days)

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

    LIFE-SHIELD PRODUCTS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CAREO Safety Syringe is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection. The CAREO Safety Syringe aids in the prevention of needlestick injuries. In addition, when the user breaks the plunger, the CAREO Safety Syringe reduces the possibility of syringe reuse.
    Device Description
    The Life-Shield Products, Inc., CAREO Safety Syringe is a sterile, single use and disposable, 3, 5, 10 mL piston syringe, provided with a permanently attached needle in twelve product configurations. The CAREO Safety Syringe is similar in appearance, size, materials, operation, and purpose to the cited predicate device and other conventional single use, sterile, disposable syringes.
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    K Number
    K030976
    Device Name
    CAREO RETRACTABLE SAFETY SYRINGE
    Date Cleared
    2003-05-30

    (63 days)

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

    LIFE-SHIELD PRODUCTS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CAREO Retractable Safety Syringe is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection. The CAREO Retractable Safety Syringe aids in the prevention of needlestick injuries. In addition, when the user breaks the plunger, the CAREO Retractable Safety Syringe reduces the possibility of syringe reuse.
    Device Description
    The Life-Shield Products, Inc., CAREO Retractable Safety Syringe is a sterile, single-use and disposable, 3 mL piston syringe, provided with a permanently attached needle in eight product configurations. The CAREO Retractable Safety Syringe is similar in appearance, size, materials, operation, and purpose to the cited predicate device and other conventional single-use, sterile, disposable syringes.
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