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510(k) Data Aggregation
K Number
K092418Device Name
ENTRACARE GASTROSTOMY FEEDING TUBE
Manufacturer
Date Cleared
2009-10-23
(78 days)
Product Code
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
ENTRACARE, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EntraCare Gastrostomy Feeding Tube is indicated for use as a replacement gastrostomy tube in an established stoma tract for patients who cannot consume an adequate diet orally. Gastrostomy feeding may be indicated for patients with a functioning stomach who require long term feeding support.
Device Description
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K Number
K053429Device Name
ADVANCED UROLOGICAL CATHETER
Manufacturer
Date Cleared
2006-02-08
(61 days)
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
ENTRACARE, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Advanced Urological Catheter is used to pass fluids to or from the urinary tract.
Device Description
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K Number
K041034Device Name
SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL)
Manufacturer
Date Cleared
2004-08-31
(132 days)
Product Code
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
ENTRACARE, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ECSL is a low profile balloon gastrostomy tube indicated for use as a replacement tube in an established stoma tract for pediatric, adult and elderly patients who cannot consume an adequate diet orally. Gastrostomy feeding may be indicated for patients who require long term feeding support. Indicated for patients in whom malnutrition already exists or may result. This may include patients for diseases resulting in an abnormality in swallowing; tumors secondary to head/neck or upper airway diseases or oropharyngeal trauma on the head, neck or overlying swallowing. Some patients who require chronic use of supplemental fluids are also candidates for gastrostomy tube use.
Device Description
The EntraCare Skin Level Gastrostomy Tube Kit (ECSL) is used as a replacement tube in an established stoma tract for patients who cannot consume an adequate diet orally. The kit consists of: Gastrostomy Tube, Elbow Connector Extension Set, Bolus Connector Extension set, Stoma Measuring Device, Universal Adapter Subassembly. Items within the kit that are supplied by an outside source: 35 ml Catheter Tipped Syringe, 6 ml Slip Luer Syringe, 4" X 4" Gauze. Item sold separately: Stoma Measuring Device. The Gastrostomy Tube consists of a Feeding Port Valve Subassembly that contains a valve used to open the fluid pathway allowing enteral feeding solutions to enter into the stomach. An inflatable balloon at the distal end secures the tube in the stomach through a stoma. The Gastrostomy Tube size variations include 14-24 French sizes and 0.8-4.5 cm length sizes. There are two slightly different valve designs available, Version 1 and Version 2. The design concept for the Gastrostomy Tube valve Version 1 utilizes a specially designed rubber mechanism that opens the fluid pathway when a bolus or elbow connector is inserted into the device. This specially designed rubber valve will seal around the connectors preventing leakage and allow unrestricted access into the fluid pathway. When the connections are removed, the valve will reseal immediately preventing leakage of fluids. The design concept for the Gastrostomy Tube valve Version 2 utilizes a specially designed silicone mechanism that opens the fluid pathway when a bolus or elbow connector is inserted into the device. This specially designed valve will seal around the connectors preventing leakage and allow unrestricted access into the fluid pathway. The Gastrostomy Tube also consists of an Inflation Valve Subassembly that contains a valve and spring mechanism. When the syringe is inserted into the Inflation Valve Subassembly, the tip pushes against the valve, which compresses the spring and opens the fluid path to inflate the balloon. The Skin Level Gastrostomy Tube Kit contains all delivery items (accessories) necessary for enteral feeding applications. The accessories provided in the kit are two Extension Sets; one that allows continuous feeding from a pump, and the other that allows feeding from a catheter tip syringe. Two syringes are supplied (which have either been previously cleared for marketing by the FDA or are pre amendment devices); the 6 ml syringe is used to inflate the balloon of the gastrostomy tube and the 35 ml catheter tip syringe is used for bolus feeding. Sterile gauze is provided for absorbency. A universal luer adapter is included for mating connections that require a female luer.
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