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510(k) Data Aggregation
K Number
K120272Device Name
AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET
Manufacturer
KENTEC MEDICAL, INC.
Date Cleared
2012-02-17
(18 days)
Product Code
KNT, PRE
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
KENTEC MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Enteral Feeding Extension Set (EFES) is intended for use as an extension set for nasogastric/ oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental misconnection with an I.V. system to the enteral system or the enteral system to an I.V. system.
Device Description
The Kentec Medical Enteral Feeding Extension Set (EFES) is a sterile disposable device for single patient use only. The device is designed to connect existing feeding tubes (nasogastric, oralgastric, gastric, etc) to various delivery enteral syringes as well as to help minimize the potential for inadvertent delivery of enteral feedings through the intravenous route. i.e., the device cannot be connected to a luer connector.
The device consist of flexible PVC tubing with an orange strip for easy quick identification of enteral feeding lines as well as a "For Enteral Feeding Only" tag and a slide clamp to provide the additional safety assurance for connection errors.
The basic set (OC-ENT-60) consists of tubing with a step connector (catheter tip) and an oral syringe connector not compatible with intravencus (I.V.) tubing or stopcocks. Other variations include:
- The basic set with shorter tubing (OC-ENT-36) t
- The basic set with step connector changed into oral syringe connector . (20C-ENT-60)
- The basic set with the addition of a "Y" site with an oral syringe connector . to allow the clinician to attach other equipment.
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K Number
K100526Device Name
AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE
Manufacturer
KENTEC MEDICAL, INC.
Date Cleared
2010-04-22
(57 days)
Product Code
FPD
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
KENTEC MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Amertius Entral™ Feeding Tube is intended for nasogastric delivery of various types of liquid nutritional media through the gastro intestinal tract of neonatal and small pediatric patients, and is not intended for use beyond 30 days.
Device Description
The Ameritus Entral™ Feeding Tubes are composed of two families of Feeding Tubes each made with different materials: polyurethane and silicone. The two families of Feeding Tubes are all made with a single lumen catheter that is used to deliver fluids as prescribed by the physician including liquid nutritional media and/or medication.
The Ameritus Entral " Feeding Tubes are sterile, individually packaged, Latex Free and DEHP Free. The orange color coding provides easy visual recognition of the enteral connection. The Ameritus Entral "" Feeding Tubes are designed with a Radiopaque stripe for X-ray visualization to confirm proper feeding tube placement. French size and length clearly printed on the feeding tube as well as centimeter markings (approx.) to assist tube placement or check for migration. A Tethered plug for connector closure is incorporated to prevent air and fluid ingress when not in use.
The device consists of the following main components: A feeding tube single lumen catheter and a connector with molded closure plug.
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K Number
K050443Device Name
ACCU-LEAD
Manufacturer
KENTEC MEDICAL, INC.
Date Cleared
2005-09-02
(192 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
KENTEC MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Single Use Only - Disposable
The NEONATAL PEDIATRIC ECG ELECRODE is intended for use whenever cardiac monitoring of neonatal or pediatric patients is deemed or desirable by trained medical or emergency personnel. This electrode is for use on the surface of the body,
Device Description
NEONATAL PEDIATRIC ECG ELECTRODE
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K Number
K970686Device Name
ACCUTEMP-PROBE
Manufacturer
KENTEC MEDICAL, INC.
Date Cleared
1997-08-25
(181 days)
Product Code
FMT
Regulation Number
880.5130Why did this record match?
Applicant Name (Manufacturer) :
KENTEC MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
There are two modes of operation for temperature control in incubators and infant warmers where these products are used, air or manual mode and baby or skin temperature control mode.
When operating in the air or manual mode, a skin temperature probe may be used just to monitor the patient's skin temperature. Here, a nurse would control the heater output manually.
When operating in the "Baby" or "Skin Temperature Control Mode" the warming units controller utilizes the skin temperature probe, connected between the controller and the infant, to automatically adjust the heater output of the unit to maintain a pre-selected skin temperature.
Device Description
There are two modes of operation for temperature control in incubators and infant warmers where these products are used, air or manual mode and baby or skin temperature control mode.
When operating in the air or manual mode, the skin temperature probe may be used just to monitor the patient's skin temperature. Here, a nurse would control the heater output manually.
When operating in the "Baby" or "Skin Temperature Control Mode" the warming units controller utilizes the skin temperature to automatically adjust the heater output of the unit to maintain a pre-selected skin temperature.
The thermistor tip which gets taped to the infant is made of a material whose resistance to electrical flow changes when the tip materials temperature changes. Two small wires run from the plug end at the incubator or warmer to the thermistor tip. One wire to each side.
A very small current goes to the tip and depending on how warm the tip is has to do with how much current returns via the other wire to the plug. That current is computed into temperatures.
These products fit the Steinhart-Hart equation which is the standard for describing thermistor curves.
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K Number
K960080Device Name
ACCUTEMP PROBE
Manufacturer
KENTEC MEDICAL, INC.
Date Cleared
1996-05-01
(111 days)
Product Code
FMT
Regulation Number
880.5130Why did this record match?
Applicant Name (Manufacturer) :
KENTEC MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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