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510(k) Data Aggregation
K Number
K100099Device Name
ORAL/ENTERAL SYRINGES
Manufacturer
PHILIPS CHILDREN'S MEDICAL VENTURES
Date Cleared
2010-06-14
(152 days)
Product Code
FPD
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS CHILDREN'S MEDICAL VENTURES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Oral/Enteral Syringes are intended for the delivery of liguid medication, formula, and breast milk.
Device Description
The Oral/Enteral Syringes are intended for the delivery of liquid medication, formula, and breast milk. The syringes incorporate safety connectors that mate with the Respironics Enteral Only Extension Set, but will not mate with Luer lock or Luer slip fittings. The safety connectors prevent inadvertent connection of the enteral system to an IV system or an IV system to the enteral system. The Oral/Enteral Syringe barrels, plungers and end caps are comprised of Polypropylene, and the pistons are comprised of Silicone.
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