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510(k) Data Aggregation
K Number
K072831Device Name
FROG
Manufacturer
Date Cleared
2008-12-12
(436 days)
Product Code
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
NEWBY-COOMBS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A non-sterile gravity medicine delivery device for use with a nasogastric or percutaneous endoscopic gastrostomy ( PEG) tube to administer crushed and diluted medications and liquids.
Device Description
The FROG is functionally similar to the syringe used for delivery of "bolus feedings and medications through a nasogastric feeding tube or a "Peg" feeding tube. By adapting the tip of the syringe barrel to accommodate the secondary medication tubing, adding a cap and hanger and enlarging the barrel of the syringe to accommodate the 240cc capacity, the FROG is capable of delivering a can (240cc) of feeding or medications, hands free and accurately without spillage or waste. The FROG is made of polypropolene, latex free and dishwasher safe for home use. The drip chamber on the delivery tubing allows for back priming in the event crushed medication particles clump and cause a blockage in the flow.
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