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510(k) Data Aggregation
K Number
K131183Device Name
MED-RX ORAL/ENTERAL SYRINGE
Manufacturer
BENLAN, INC.
Date Cleared
2014-06-03
(403 days)
Product Code
KNT, PRE
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
BENLAN, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MED-RX® Oral/Enteral Syringes are to be used by a healthcare professional to measure and administer oral medication and enteral nutrition. The MED-RX® Oral/Enteral Syringes are sterile, single use, and for pediatric use only.
Device Description
The MED-RX® Oral/Enteral Syringe is available in two configurations, an enteral tip syringe and an overmolded enteral tip syringe. Both configurations of the MED-RX® Oral/Enteral Syringe are available in various volumes, from 1 to 60mL. All MED-RX® Oral/Enteral Syringe feature graduation markings along the barrel of the syringe, are provided with a tip cap, and are incompatible with standard luer devices. The MED-RX® Oral/Enteral Syringes are provided sterile, and are single use and disposable.
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K Number
K100700Device Name
MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES
Manufacturer
BENLAN, INC.
Date Cleared
2010-12-13
(276 days)
Product Code
FPD, FDP
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
BENLAN, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MED-RX Pediatric Feeding Tube and Accessories are disposable, single use enteral feeding devices featuring non-luer enteral only connectors. The MED-RX Pediatric Feeding Tube is intended to be used for nasogastric enteral feeding, as directed by a physician. The MED-RX Enteral Extension Set is an accessory to the MED-RX Pediatric Feeding Tube, to be used to deliver fluids from the nutritional source to an existing non-luer pediatric feeding tube. The MED-RX Pediatric Feeding Tube and Accessories are for hospital use, pediatric patient use only, and are not intended for use beyond 30 days.
Device Description
The MED-RX Pediatric Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician. Accessories to be offered alongside the MED-RX Pediatric Feeding Tubes include MED-RX Enteral Extension Sets of various configurations. The MED-RX Enteral Extension Set is intended to be used to deliver fluids from the nutritional source to an existing non-luer pediatric feeding tube. The MED-RX Pediatric Feeding Tubes and Enteral Extension Sets feature non-luer enteral only connectors to decrease the risk of accidental misconnection. All devices are sterile, single-use, and latex free. The MED-RX Pediatric Feeding Tube and Accessories are for pediatric use only. Accessories may be sold with MED-RX Pediatric Feeding Tubes or separately.
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K Number
K102073Device Name
MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS
Manufacturer
BENLAN, INC.
Date Cleared
2010-11-08
(108 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
BENLAN, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MED-RX Transfer Set is intended to be used in the delivery of contrast media or saline from a spikeable container into a syringe.
Device Description
The MED-RX Transfer Set is offered in four (4) different models: 10-1227TS, 10-1300TS, 10-1305TS, and 10-1306TS. The MED-RX Transfer Set is intended to be used in the delivery of contrast media or saline from a spikeable container into a syringe. The MED-RX Transfer Sets each consist of a spike, tubing, and either a valve (swabbable or dual check) or 3-way stopcock. All sets but the 10-1306TS also have a pinch clamp. The tube is made of polyvinyl chloride (PVC) and is available in lengths from 18″ – 44″. The MED-RX Transfer Sets are provided sterile and are not to be resterilized.
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K Number
K010607Device Name
MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001
Manufacturer
BENLAN, INC.
Date Cleared
2001-11-28
(272 days)
Product Code
LJH
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
BENLAN, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K990777Device Name
MED-RX EXTENSION SETS
Manufacturer
BENLAN, INC.
Date Cleared
1999-08-25
(169 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
BENLAN, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These extension sets are sterile, single use, medical devices intended for use in LV. therapy when extended fluid path is required for fluid or drug administration. Benlan Inc. does not cause or promote new intended uses for these devices.
Device Description
The Med-RX® Extension Sets consist mainly of a fluid delivery tubing provided with capped luer connectors at the proximal ends. The extension sets can thus be connected to an I.V. administration sets whereby extending infusion site(s) of a primary I.V. catheter. The fluid delivery tubing can vary in lengths as well as bore sizes, i.e. standard bore, mini-bore and micro-bore. The extension sets may include pinch or slide clamps.
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