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510(k) Data Aggregation
K Number
K231299Device Name
Nutricair enteral ENFit adapter: ENFit male stepped/Christmas tree connector
Manufacturer
Cair LGL
Date Cleared
2024-01-22
(263 days)
Product Code
PIO
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
Cair LGL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nutricair enteral ENFit adapter: ENFit male - stepped/Christmas tree connector is a disposable, sterile medical device intended to be used as an adapter between ENFit connections and funnel connections, used in enteral nutrition. A doctor, a nurse or the adult laypersons can do enteral feeding. The target population is adults.
Device Description
The Nutricair™ enteral ENFit adapter: ENFit male – stepped/Christmas tree connector is sterile single use device. The adapter presents a ENFit connection in ABS at one extremity and a notched connection (in ABS) at the other extremity. The device has also a female ENFit cap in PEHD attached to the adapter with a link. This device incorporates a male ENFit connection to enteral access device with a female ENFit connector that is compliant to ISO 80369-3. It is provided with a sterility protector.
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K Number
K231300Device Name
Nutricair Enteral Syringe with ENFit
Manufacturer
Cair LGL
Date Cleared
2023-10-06
(155 days)
Product Code
PNR
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
Cair LGL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NUTRICAIR™ enteral feeding syringes with ENFit® are disposable, sterile medical devices that are intended for the measurement, the preparation and enteral administration of solutions (hydration, feeding) or medications for neonatal, pediatric and adult patient populations. These devices are intended to be used in clinics and home care settings by: - health care professionals - adult laypersons (instructed by/or under the supervision of health care professionals).
Device Description
The Nutricair™ enteral syringe with ENFit is sterile, single use device. It is provided in size 10 ml. It consists in a body with ENfit connector in polypropylene, a plunger in polypropylene and a piston seal in isoprene. This device incorporates a female ENFit connection to enteral access device with a male ENFit connector that is compliant to ISO 80369-3. Graduations from 1 to 10 ml are printed on the body. The 10 mL syringe model number is NCE10SE.
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K Number
K213258Device Name
Nasogastric Feeding Tubes - ENFit Port - PVC
Manufacturer
Cair Lgl
Date Cleared
2022-06-09
(252 days)
Product Code
PIF
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
Cair Lgl
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nasogastric Feeding Tubes – ENFit Port - PVC are intended for hydration, feeding and administration of oral medications for patients who require enteral feeding. This product is single use for no longer than 24 hours.
Device Description
The Nasogastric Feeding Tubes – ENFit Port - PVC are sterile, single use devices. The feeding tubes consist of a graduated polyvinyl chloride tube, with radiopaque edge. The tubes have a closed tip and two lateral eyes for Fr sizes 5 to 10 and three lateral eyes for Fr sizes 12 to 16. The tubes have at the other end an ENFit male connector in ABS with its Polypropylene cap. A tether in thermoplastic polyurethane connects the ENFit connector to its cap. The ENFit connector allows the device to be connected to female enteral devices that have an ISO 80369-3 compliant connector. The feeding tubes are available in 50cm and 90cm lengths and in French sizes from 5 to 16.
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K Number
K210598Device Name
Pediatric Nasogastric Feeding Tubes - Single ENFit Port
Manufacturer
CAIR LGL
Date Cleared
2021-11-02
(246 days)
Product Code
PIF
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
CAIR LGL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pediatric Nasogastric Feeding Tubes - Single ENFit Port are intended for enteral feeding to deliver nutrition, fluids, and medications to the patient from an enteral feeding syringe or feeding set designed with ENFit connectors for enteral applications. This product is single use for no longer than 29 days.
The Pediatric Nasogastric Feeding Tubes – Single ENFit Ports are intended for hydration, feeding and administration of oral medications for pediatric patients who require enteral feeding. This product is single use for no longer than 29 days.
Device Description
The Pediatric Nasogastric Feeding Tubes – Single ENFit Port are sterile, single use devices. The feeding tubes consist of a graduated Polyurethane tube, with radiopaque edge. The tubes have a closed tip and 2 lateral eyes. The tubes have at the other end an ENFit male connector in ABS with its Polypropylene cap. A tether in thermoplastic polyurethane connects the ENFit connector to its cap. The ENFit connector allows the device to be connected to female enteral devices that have an ISO 80369-3 compliant connector. The feeding tubes are available in 40mm, 60mm and 90mm lengths and in French sizes from 4 to 12.
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K Number
K171132Device Name
Carefusion NeutraClear Needle-free connector
Manufacturer
CAIR LGL
Date Cleared
2017-07-31
(105 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
CAIR LGL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Carefusion NeutraClear™ Needle-free connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration sets for the administration or withdrawal of fluids from a patient through a cannula placed in the vein or for withdraw of fluids through the artery. Carefusion NeutraClear™ Needle-free connector may be used with low-pressure power injectors with a flow at 10ml/s, in state of connection.
Device Description
Carefusion NeutraClear™ Needle-free connector is a bidirectional needleless injection valve. The Carefusion NeutraClear™ Needle-free connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration sets for the administration or withdrawal of fluids from a patient through a cannula placed in the vein or for withdraw of fluids through the artery. Carefusion NeutraClear™ Needle-free connector may be used with low-pressure power injectors with a flow at 10 ml/s, in state of connection.
Carefusion NeutraClear™ Needle-free connector is intended for single patient use in intravenous and blood administration sets without need for needles, thus eliminating the potential for needle-stick injuries during use. The subject device is not intended to treat existing infections. The device is not intended to have any effect on contaminated infusion solutions.
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K Number
K133073Device Name
CAIR DRIVE, NEUTRACLEAR
Manufacturer
CAIR LGL
Date Cleared
2014-03-20
(171 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
CAIR LGL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bidirectional needleless injection valve is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration sets for the administration or withdrawal of fluids from a patient through a cannula placed in the vein or for withdraw of fluids through the artery. Bidirectional needleless injection valve may be used with low-pressure power injectors with a flow at 10 ml/s, in state of connection.
Device Description
The CAIR LGL valves features include a smooth swappable septum surface, septum seal integrity with no gaps or openings, a microbial physical barrier, straight through fluid pathway, zero dead space, zero fluid displacement low priming volume, saline-only flush option and no clamping sequence or positive pressure syringe technique required.
The Cair bidirectional needleless injection valve may be used with low pressure power injectors having a pressure of 7 bars with a luer lock connection.
The subject device is composed of materials (polycarbonate, silicone) that have been successfully and safely used in medical devices including the predicate device. The materials used in the subject device have been subjected to and passed biocompatibility testing.
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