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Found 13 results
510(k) Data Aggregation
K Number
K162110Device Name
CORGRIP NG/NI Tube Retention System
Manufacturer
CORPAK MedSystems, Inc. a Division of Haylard Health
Date Cleared
2016-09-15
(48 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
CORPAK MedSystems, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CORGRIP Nasogastric/Nasointestinal (NGNI) Tube Retention System is indicated for use with enteral feeding tubes of 8 FR and greater and NG decompression, suction and drainage tubes up to 18 FR to prevent inadvertent removal or displacement of the tubes for adult patients.
Device Description
The CORGRIP NG/NI Tube Retention System is an accessary to prevent unwanted displacement or removal of nasogastric/nasojejunal tubes for adult patients by retaining the tube to the patient's nasal septum. The device consists of three main components: insertion (delivery) catheter, retrieval catheter, and tube clamp.
The catheters are placed in either nare of the patient and the clinician maneuvers the catheters to connect the magnets at the back of the patient's nasal septum. Both catheters have a flexible tip to aid in magnet connection. Once connection is made the magnet on the insertion catheter is pulled through the nare by the retrieval catheter. Both catheters are then removed from each nare until the ends of the umbilical tape are exiting either nare. The umbilical tape is then secured to the feeding tube with the provided clamp.
The proposed device adds the option of a 14, 16 and 18 Fr clamp.
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K Number
K142012Device Name
FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS
Manufacturer
CORPAK MEDSYSTEMS
Date Cleared
2014-11-20
(119 days)
Product Code
PIF
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
CORPAK MEDSYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FARRELL® Valve System with EQUILIBRIUM TECHNOLOGY™ and ENFit™ Enteral Connectors is a closed reservoir system intended to allow the evacuation of excess gas (gastric distention/bloating) and drainage/collection of enteral feeding formula and gastrointestinal tract contents from patients utilizing an enteral device. The FARRELL® Valve System with EQUILIBRIUM TECHNOLOGY™ and ENFit™ Enteral Connectors is for use with neonates, pediatric, and adult patients.
Device Description
Not Found
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K Number
K133599Device Name
CORGRIP
Manufacturer
CORPAK MEDSYSTEMS
Date Cleared
2014-03-26
(121 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
CORPAK MEDSYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CORGRIP Nasogastric/Nasointestinal (NG/NI) Tube Retention System is indicated for use with CORPAK MedSystems enteral feeding tubes of 8 Fr and greater to prevent inadvertent removal or displacement of the tubes for adult patients.
Device Description
Not Found
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K Number
K131532Device Name
ELECTROMAGNETIC TRANSMITTING STYLET
Manufacturer
CORPAK MEDSYSTEMS
Date Cleared
2013-08-12
(76 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
CORPAK MEDSYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Electromagnetic Transmitting Stylet has been specifically designed for use with the CORTRAK 2 Enteral Access System (EAS), and is intended to aid in the confirmation of NG decompression tubes.
Device Description
Electromagnetic Transmitting Stylet
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K Number
K113351Device Name
CORTRAK ENTERAL ACCESS DEVICE
Manufacturer
CORPAK MEDSYSTEMS
Date Cleared
2012-01-10
(57 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
CORPAK MEDSYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CORTRAK 2 System is an electrical device designed to aid qualified operators in the placement of the CORPAK MedSystems feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding. CORTRAK 2 can be used to confirm placement of feeding tubes prior to commencing the delivery of enteral nutrition.
Device Description
The CORTRAK 2 System is an electrical device.
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K Number
K100365Device Name
FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV
Manufacturer
CORPAK MEDSYSTEMS
Date Cleared
2010-05-20
(97 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
CORPAK MEDSYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Farrell Valve is a reservoir system intended to allow the evacuation of excess gas(gastric distention/bloating) and enteral feeding formula from the stomach of patients receiving enteral formula via feeding tubes and sets. Farrell Valve with CORFLO ANTI IV Connectors is for use with pediatric patients.
Device Description
Not Found
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K Number
K091637Device Name
CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
Manufacturer
CORPAK MEDSYSTEMS
Date Cleared
2009-09-29
(117 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
CORPAK MEDSYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K083776Device Name
CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S
Manufacturer
CORPAK MEDSYSTEMS
Date Cleared
2009-03-05
(76 days)
Product Code
FPD
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
CORPAK MEDSYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CORFLO Anti-IV Enteral Feeding Extension Set is intended to be used to deliver enteral formula from the nutritional source to any enteral feeding device accepting standard enteral step connectors. The CORFLO Anti-IV Enteral Feeding Extension Set is for pediatric and neonatal use only.
Device Description
CORFLO Anti-I.V. Enteral Feeding Extension Set Model# 20-1030AIV-LB-S
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K Number
K083791Device Name
CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S
Manufacturer
CORPAK MEDSYSTEMS
Date Cleared
2009-03-04
(75 days)
Product Code
FPD
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
CORPAK MEDSYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CORFLO Anti-I.V. Enteral Feeding Extension Set is intended to be used to deliver enteral formula from the nutritional source to any enteral feeding device acccepting a standard enteral step connector. The CORFLO Anti-IV Enteral Feeding Extension Set is for pediatric and neonatal use only.
Device Description
Not Found
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K Number
K083786Device Name
CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB
Manufacturer
CORPAK MEDSYSTEMS
Date Cleared
2009-02-20
(63 days)
Product Code
FPD
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
CORPAK MEDSYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CORFLO Anti-IV Enteral Feeding Extension Set is intended to be used to deliver enteral formula from the nutritional source to the Anti IV Enteral feeding tube. The CORFLO Anti-IV Enteral Feeding Extension Set is for pediatric and neonatal use only.
Device Description
Not Found
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