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510(k) Data Aggregation
K Number
K232205Device Name
Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag Feed Set; Vesco Q 40mm Screw Cap Feed Set; Vesco Q ENPlus Feed Set
Manufacturer
Vesco Medical, LLC
Date Cleared
2023-10-23
(90 days)
Product Code
LZH
Regulation Number
880.5725Why did this record match?
Product Code :
LZH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vesco Q™ Enteral Feeding Pump System is intended to be used by healthcare professionals, patients and caregivers for the intermittent and continuous delivery of enteral fluids for adult and pediatric (infant, child, and adolescent) feeding therapy in hospital and home care environments.
Device Description
The Vesco Q™ Enteral Feeding Pump System is comprised of an enteral infusion pump and disposable enteral feed sets. The Vesco Q™ Pump is a rotary peristaltic pump engineered to deliver doses of enteral fluids at selectable rates programmed with a newly designed purpose- specific touchscreen interface. The pump body is designed to be ergonomic and portable. The Vesco Q™ Feed Sets are non-sterile, single patient use enteral feed sets that are designed to be anti-free flow until the pump is running. The feed sets are designed with cassettes for the simple loading of the feed set without a pump door. The feed sets incorporate a female ENFit connector which is compatible with devices that have male ENFit connectors. The ENFit connectors are being implemented within enteral feeding devices to eliminate misconnection with non-enteral feeding devices.
Vesco Q™ Feed Sets are available in three different feed set styles: Bag Feed Sets, ENPlus Feed Sets and Screw Cap Feed Sets. All of the feed sets are made of flexible PVC tubing, a silicone tube, a feed set to pump interface, and a plastic ENFit female connecting port. Bag Feed Sets are available in two different volumes, 500mL and 1000mL. The difference between each feed set is how the liquid nutrition is introduced to the set. The Bag Feed Set has a translucent film bag, the Safety Screw Spike Feed Set has a plastic spike connector, and the Screw Cap Feed Set has a plastic 40mm threaded opening to connect to feed containers.
The connectors on the proximal end of the extension sets are ENFit ISO 80369-3 compliant. The ENFit connector allows for connections of enteral specific applications while reducing the likelihood of misconnections to non-enteral devices.
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K Number
K221603Device Name
Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml (B5FD );Kangaroo OMNI ENtelliSet 500ml (E5FD );Kangaroo OMNI Feeding Set 1000ml (B10FD );Kangaroo OMNI ENtelliSet 1000ml (E10FD );Kangaroo OMNI ENPlus Spike Set (BSPFD );Kangaroo OMNI ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI
Manufacturer
Cardinal Health LLC
Date Cleared
2022-12-20
(201 days)
Product Code
LZH
Regulation Number
880.5725Why did this record match?
Product Code :
LZH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for delivery of enteral fluids, including nutritional fluids and/or water to the gastrointestinal system via nasogastric, orogastric, nasojejunal, gastrostomy, and jejunostomy tubes. Not for use with neonates. Intended for any patients ages infant, child/adolescent and adult who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing. Intended to be used in hospital and acute care settings, as well as long term and home care settings by users ranging from clinicians to laypersons and patients. Some patients may need a caregiver to support using the device. It is intended to be used in both stationary and ambulatory conditions including ground and air transport while using backpack accessory.
The Kangaroo OMNI™ Enteral Feeding Pump and Feeding Set are intended to be used together as a system. Kangaroo OMNI™ Enteral Feeding Sets for administration of standard formula are able to be connected to access devices of all sizes that are ENFit™ compatible. The Kangaroo OMNI™ Thick Formula Feeding Sets for administration of thick formula can be used with access devices 8 Fr size or greater that are ENFit™ compatible.
Device Description
The Kangaroo OMNI™ Enteral Feeding Pump, Kangaroo OMNI™ Feeding Sets and Kangaroo™ Accessories consist of an enteral feeding pump and disposable enteral feeding sets along with accessories that deliver fluids via rotary peristaltic tension loop pumping to provide hydration and nutrition for those who do not have the ability to orally ingest food or drinks.
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K Number
K220230Device Name
AMSure Enteral Feeding Pump
Manufacturer
Amsino International Inc.
Date Cleared
2022-11-10
(287 days)
Product Code
LZH
Regulation Number
880.5725Why did this record match?
Product Code :
LZH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AMSure® Enteral Feeding Pump is intended to work with the disposable enteral feeding sets to deliver nutritional formula to the gastrointestinal system of adult patients who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing.
Only intended for adult patients, not for pediatric use.
The AMSure® Enteral feeding pump is intended to be used in healthcare facilities by licensed healthcare professional users only.
The AMSure® Enteral feeding pump is for use only with Amsino AMSure® feeding sets.
Device Description
The AMSure® enteral feeding pump is intended to work with the disposable enteral feeding sets that deliver formula via rotary peristaltic pumping system to provide nutrition for those who do not have the ability to orally ingest food
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K Number
K200051Device Name
PUGGLE Enteral Feeding Pump and Feeding Set
Manufacturer
Amsino International Inc.
Date Cleared
2020-09-25
(259 days)
Product Code
LZH
Regulation Number
880.5725Why did this record match?
Product Code :
LZH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PUGGLE® Enteral Feeding Pump and Feeding Set are intended to deliver nutritional formula to the gastrointestinal system of a patient age infant and older who is physically unable to eat and swallow. Not for use with neonates. The PUGGLE® Enteral Feeding Pump and Feeding Set are intended to be used in clinical or home care settings by users ranging from laypersons to physicians. The PUGGLE® Enteral Feeding Pump and Feeding Set shall be used together only.
Device Description
The PUGGLE® Enteral Feeding Pump and Feeding Set consists of an enteral feeding pump and disposable enteral feeding sets that deliver formula via rotary peristaltic pumping system to provide nutrition for those who do not have the ability to orally ingest food. The pump incorporates a graphical interface that walks the users through the PUGGLE® Enteral Feeding Pump and Feeding Set setup feed rates and volumes as well as other feeding options. The PUGGLE® Enteral Feeding Pump and Feeding Set come with three different connector types: standard, ENFit®, and ENFit® with Transition Connector.
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K Number
K153074Device Name
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
Manufacturer
COVIDIEN
Date Cleared
2016-07-06
(258 days)
Product Code
LZH
Regulation Number
880.5725Why did this record match?
Product Code :
LZH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets is intended to deliver nutritional formula to the gastrointestinal system of a patient age infant and older who is physically unable to eat and swallow. Not for use with neonates. The feeding pump and feeding sets are intended to be used in clinical or home care settings by users ranging from laypersons to physicians.
Device Description
The Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets and Kangaroo™ Connect Portal consists of a wireless enabled enteral feeding pump and disposable enteral feeding sets that deliver formula via rotary peristaltic tension loop pumping to provide nutrition for those who do not have the ability to orally ingest food. The new Kangaroo™ Connect Enteral Feeding Pump wireless accessories include a communication hub and the Kangaroo™ Connect Portal. The communication hub collects short-range data from the pump through a Zigbee signal and sends the data through either WiFi or a cellular signal to the device cloud where the Kangaroo™ Connect Portal can access the data for monitoring. The wireless enabled pump, when used in conjunction with the wireless accessories, will provide a platform for remote data collection allowing clinicians to more efficiently monitor feeding rates and review actual history of nutritional delivery.
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K Number
K143263Device Name
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
Manufacturer
COVIDIEN
Date Cleared
2015-05-29
(197 days)
Product Code
LZH
Regulation Number
880.5725Why did this record match?
Product Code :
LZH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets delivers nutritional formula to the gastrointestinal system of a patient age infant and older who is physically unable to eat and swallow. Not for use with neonates. The feeding pump and feeding sets are intended to be used in clinical or home care settings by users ranging from laypersons to clinicians.
Device Description
Enteral feeding pump and disposable enteral feeding sets
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K Number
K141479Device Name
KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS
Manufacturer
COVIDIEN
Date Cleared
2014-12-23
(202 days)
Product Code
LZH
Regulation Number
880.5725Why did this record match?
Product Code :
LZH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kangaroo™ Enteral Feeding Set with ENFit connectors delivers nutritional formula to the gastrointestinal system of a patient age Infant and older who is physically unable to eat and swallow. Not for use with neonates. The feeding sets are intended to be used in clinical or home care settings by users ranging from laypersons to clinicians.
Device Description
Enteral Feeding sets for use with Kangaroo Feeding pumps. The pump set incorporates 5 basic segments: Fluid reservoir(s), which may be an attached bag (500ml or 1000ml) or a spike for connection to a formula container; Tubing from fluid reservoir to pump (9 or 24 inch); Pump interface module (peristaltic tubing); Tubing from pump to patient connector (66 inches); Patient connector (ENFit connector compliant to ISO 80369-3).
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K Number
K131154Device Name
ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET;
Manufacturer
ZEVEX, INC.
Date Cleared
2014-02-12
(294 days)
Product Code
LZH
Regulation Number
880.5725Why did this record match?
Product Code :
LZH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EnteraLite® Infinity® Enteral Feeding Pump is a rotary peristaltic pump designed to deliver programmed doses of enteral nutrition solutions at selectable rates.
Device Description
The EnteraLite® Infinity® Enteral Feeding Pump as referred to as Infinity® with disposable set is a small, lightweight pump used to dispense liquid nutrients at a user controlled rate to patients. The device may be used in the hospital or at home by bedridden or ambulatory patients. The device is also designed for use with pediatric patients.
The device is software controlled, variable flow rate, peristaltic pump. It operates up to 24 hours (at a nominal flow rate of 125 ml/hr) from internal rechargeable batteries. The batteries are recharged by a wall mounted charger that plugs into a standard 100 to 240 volt alternating current wall socket. The charger is available in various input voltage and plug configurations to accommodate international requirements. The charger converts line voltage to a safe low voltage of 5 volts DC that is supplied from the charger to the pump. A "fuel gauge" type indicator on the pump's LCD display continuously shows the state of battery charge.
The pump motor runs at a single speed and is turned on and off at programmed intervals to obtain the desired flow rate. The motor drive circuit is controlled by a microcontroller that allows the motor to pause longer at lower flow rates with correspondingly shorter pauses at higher flow rates. The software embodied within the microcontroller is validated and verified as part of the design process.
The pump includes several safety features. An air-in-line sensor rapidly detects whenever nutrient flow is interrupted and alerts the user with both a visual and audible alarm. Two pressure sensors detect occlusions both on the nutrient bag (distal) side and the patient (proximal) side of the pump. The user is alerted to proximal or distal occlusions by both visual and audible alarms.
The disposable tubing set consists of a bag, or spike for nutrient bag, PVC connecting tubing, an integral cassette with a silicone pumping segment, and an enteral adapter. The set also contains a patented anti-free flow device within the cassette, which prevents free flow of fluids if the tubing set is inadvertently or purposely removed from the pump.
A backpack (convertible to a waistpack) is available for use under ambulatory conditions. The pump may be operated in any orientation.
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K Number
K111381Device Name
MEDI-SIS SYRINGE INFUSION SYSTEM
Manufacturer
ACACIA, INC.
Date Cleared
2012-01-13
(241 days)
Product Code
LZH
Regulation Number
880.5725Why did this record match?
Product Code :
LZH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1.0 The Medi-SIS Syringe Infusion System is indicated for the delivery of enteral fluids through clinically accepted routes of administration.
2.0 The Medi-SIS Administration Extension Set is intended for single patient use only.
3.0 The Medi-SIS Syringe Driver can be reused up to 5,000 times
Device Description
The Medi-SIS Syringe Infusion System consists of a Syringe Driver (mechanical syringe pump), proprietary administration extension set, and compatible syringe.
The Medi-SIS Syringe Driver consists of a mechanical syringe pump assembly that is manufactured from plastic housings and end caps, and steel spring (mechanical force from the spring presses against the syringe plunger), and holds a 30mL or 60mL Becton Dickinson syringe (preamendment device) or a 30mL or 60mL Acacia syringe (K092986). The Medi-SIS Syringe Driver must be used in conjunction with a Medi-SIS Administration Extension Set, which controls the time the infusion will occur (by flow restrictor) for the entire volume of the filled syringe. The Medi-SIS Syringe Infusion System infuses fluids in a continuously decreasing rate and the user can calculate the average flow rate based from volume and time infused.
The Medi-SIS Syringe Driver is reusable and provided non-sterile.
The Medi-SIS Administration Set consists of various lengths of flexible non-DEHP PVC tubing. on/off clamp, flow restrictor, and male and female connectors. The male and female connectors meet Acacia's internal specifications for enteral applications to ensure cross connections do not occur between IV and Enteral infusions. Additional componentry may be added and configurations modified based on the needs of clinicians.
The following Administration Extension Sets will be available:
60mL Syringe Size, 1.0mL per minute delivery rate 60mL Syringe Size, 2.0mL per minute delivery rate 30mL Syringe Size, 0.5mL per minute delivery rate 30mL Syringe Size, 1.0mL per minute delivery rate 30mL Syringe Size. 2.0mL per minute delivery rate
The approximate residual volume for the syringe/administration set combination is approximately 2.20mL for all configurations. The Medi-SIS Administration Extension Set is provided sterile, single use, and non-pyrogenic.
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K Number
K060316Device Name
COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
Manufacturer
FRESENIUS KABI DEUTSCHLAND GMBH
Date Cleared
2006-06-23
(135 days)
Product Code
LZH
Regulation Number
880.5725Why did this record match?
Product Code :
LZH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Compat GOTM feeding pump with the administration sets are intended exclusively for enteral feeding. The purpose of this administration system is the delivery of Enteral nutrition at controlled rates (pump assisted) to patients gastrointestinal system. Intended for us for patient with any condition requiring Enteral feeding and Enteral hydration. The Compat GOTM Enteral Feeding Pump and the Compat GOTM Enteral Administration Sets are intended to use by adults or paediatric in hospital and home care environments, both in stationary and ambulatory ways.
Device Description
The Compat GOTM Enteral Feeding Pump ( a Class II device) and Enteral Administration Sets are designed to deliver formulas and Enteral hydration liquids via linear peristaltic pumping to provide nutrition for patients which are not able to ingest food orally. The Compat GOTM Enteral Feeding_System is working with the Compat GO™ Enteral Feeding Pump and the Compat GOTM Enteral Administration Sets only caused by its adapted safety and effectiveness concept. The Compat GOTM Enteral Administration Sets are compatible with the standard prefilled formula containers presently available on the market. The Compat GO™ Enteral Administration Sets are designed to compatible with present market Enteral access devices and accessories.
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