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510(k) Data Aggregation
K Number
K180683Device Name
Certa Dose Pediatric Midazolam 5mg/mL IM Syringe
Manufacturer
Date Cleared
2018-11-07
(237 days)
Regulation Number
880.5860Why 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
K160589Device Name
Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe
Manufacturer
Date Cleared
2017-01-19
(324 days)
Regulation Number
880.5860Why 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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