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510(k) Data Aggregation

    K Number
    K180683
    Device Name
    Certa Dose Pediatric Midazolam 5mg/mL IM Syringe
    Manufacturer
    Date Cleared
    2018-11-07

    (237 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    PQX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Certa Dose™ Pediatric Midazolam 5 mg/mL intramuscular (IM) Syringe is intended for the delivery of midazolam 5 mg/mL for use in pediatric (non-neonatal) patients up to 30kg in weight.
    Device Description
    The Certa Dose™ Pediatric Midazolam 5 mg/mL IM Syringe is comprised of (A) a 510(k)-cleared Monoject 1mL Tuberculin Syringe with a regular tip, non-luer lock (K850190), and (B) a plastic overlay which provides barrel markings. The items on the overlay include (1) a zero line, (2) 0.01 mL unit graduation markings, (3) secondary graduation markings at 0, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.9, 1.0 mL, (4) color bars, and (5) the name of the drug for which the syringe is indicated, midazolam 5 mg/mL.
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    K Number
    K160589
    Device Name
    Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe
    Manufacturer
    Date Cleared
    2017-01-19

    (324 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    PQX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Certa Dose™ PD Epinephrine 1 mg/mL IM/SC Syringe is intended for healthcare professionals to deliver epinephrine 1 mg/mL via intramuscular or subcutaneous injection for pediatric patients.
    Device Description
    The Certa Dose™ PD Epinephrine 1 mg/mL IM/SC Syringe is comprised of (A) a 3/10mL Syringe with an attached 29 Gauge x ½ inch Needle, and (B) a plastic overlay which provides barrel markings. The items on the overlay include (1) a zero line, (2) 0.01 mL unit graduation markings, (3) secondary graduation markings at 0, 0.05, 0.10, 0.15, 0.20, 0.25, 0.30 mL, (4) color bars, and (5) the name of the drug for which the syringe is indicated, epinephrine 1 mg/mL.
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