No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10816340022124 | ND36EO-HF | 36" High-flow extension set with non-IV enteral only adapter | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
2 | 10816340022117 | ND-BF20 | Blood filter 17 micron | FPA | Set, Administration, Intravascular | 2 | NeoDevices, Inc. | |
3 | 10816340022100 | BBS1 | Blood bag spike set | FPA | Set, Administration, Intravascular | 2 | NeoDevices, Inc. | |
4 | 10816340022094 | ND72DT | 72" Mini-Bore Extension Set with dark tubing, male/female | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
5 | 10816340023060 | NDS24EO-HF | 24 inch high flow extension set with non-IV enteral only adapter | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
6 | 10816340023053 | ND-S60EL | 60cc Oral dose syringe | KNT,FPD | Tubes, Gastrointestinal (And Accessories),Tube, Feeding | 2 | NeoDevices, Inc. | |
7 | 10816340023046 | ND-S30EL | 30cc Oral dose syringe | FPD,KNT | Tube, Feeding,Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
8 | 10816340023039 | ND-S20EL | 20cc Oral dose syringe | KNT,FPD | Tubes, Gastrointestinal (And Accessories),Tube, Feeding | 2 | NeoDevices, Inc. | |
9 | 10816340023015 | ND-S5EL | 5cc Oral dose syringe | KNT,FPD | Tubes, Gastrointestinal (And Accessories),Tube, Feeding | 2 | NeoDevices, Inc. | |
10 | 10816340023008 | ND-S3EL | 3cc Oral dose syringe | FPD,KNT | Tube, Feeding,Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
11 | 10816340022131 | ND24EO-HF | 24" High-flow extension set with non-IV enteral only adapter | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
12 | 10816340022087 | ND60EOY | 60" Bifurcated Orange Stripe Extension Set with non-IV Stepped Adapter and enter 60" Bifurcated Orange Stripe Extension Set with non-IV Stepped Adapter and enteral only connector with 2" orange stripe tube with enteral only connector | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
13 | 10816340022070 | ND60EO | 60" Orange Stripe Extension set with non-IV enteral stepped adapter and enteral 60" Orange Stripe Extension set with non-IV enteral stepped adapter and enteral only connector | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
14 | 10816340022063 | ND36EOY | 36" Bifurcated Orange Stripe Extension Set with non-IV Stepped Adapter and enter 36" Bifurcated Orange Stripe Extension Set with non-IV Stepped Adapter and enteral only connector with 2" orange stripe tube with enteral only connector | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
15 | 10816340022056 | ND36EO | 36" Enteral Extension set with non-IV stepped adapter and enteral only connector | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
16 | 10816340022049 | ND60E-LL | 60" Orange Stripe Extension Set with IV adaptable enteral stepped adapter and fe 60" Orange Stripe Extension Set with IV adaptable enteral stepped adapter and female luer lock | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
17 | 10816340022032 | ND60EN-L | 60" Enteral Extension Set with large non-IV stepped adapter and female luer lock | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
18 | 10816340022025 | ND60ENY-C | 60" Bifurcated Orange Stripe Extension Set with non-IV Enteral Stepped Adapter w 60" Bifurcated Orange Stripe Extension Set with non-IV Enteral Stepped Adapter with female luer lock and 2" orange stripe tube with universal adapter | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
19 | 10816340022018 | ND60EN | 60" Orange Stripe Extension Set with non-IV enteral stepped adapter and female luer lock | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
20 | 10816340022001 | ND36EN | 36" Orange Stripe Extension Set with non-IV enteral stepped adapter and female luer lock | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
21 | 10816340021592 | FTL8.0P-EL | 8.0Fr, 90cm Polyurethene Enteral Locking Feeding tube with orange radiopaque str 8.0Fr, 90cm Polyurethene Enteral Locking Feeding tube with orange radiopaque strip (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
22 | 10816340021585 | ND60EOY-EL | 60" Bifurcated Orange Stripe Extension Set with Enteral Locking connectors (ISO 60" Bifurcated Orange Stripe Extension Set with Enteral Locking connectors (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
23 | 10816340021578 | ND60EOY-EF | 60" Bifurcated Orange Stripe Extension Set with EnFit connectors (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
24 | 10816340021561 | ND24EL-HF | 24" High Flow Orange Stripe Extension set with Enteral Locking Connectors (IS 24" High Flow Orange Stripe Extension set with Enteral Locking Connectors (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
25 | 10816340021554 | ND24EF-HF | 24" High Flow Orange Stripe Extension set with EnFit Connectors (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
26 | 10816340021547 | ND36-EL | 36" Orange Stripe Extension set with Enteral Locking Connectors (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
27 | 10816340021530 | ND36-EF | 36" Orange Stripe Extension set with EnFit Connectors (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
28 | 10816340021523 | ND60-EL | 60" Orange Stripe Extension set with Enteral Locking Connectors (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
29 | 10816340021516 | ND60-EF | 60" Orange Stripe Extension set with EnFit Connectors (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
30 | 10816340021509 | FTL8.0S-EL | 8.0Fr, 90cm Silicone Enteral Locking Feeding tube with orange radiopaque strip ( 8.0Fr, 90cm Silicone Enteral Locking Feeding tube with orange radiopaque strip (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
31 | 10816340021493 | FTM8.0S-EL | 8.0Fr, 60cm Silicone Enteral Locking Feeding tube with orange radiopaque strip ( 8.0Fr, 60cm Silicone Enteral Locking Feeding tube with orange radiopaque strip (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
32 | 10816340021486 | FTS8.0S-EL | 8.0Fr, 40cm Silicone Enteral Locking Feeding tube with orange radiopaque strip ( 8.0Fr, 40cm Silicone Enteral Locking Feeding tube with orange radiopaque strip (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
33 | 10816340021479 | FTL6.5S-EL | 6.5Fr, 90cm Silicone Enteral Locking Feeding tube with orange radiopaque strip ( 6.5Fr, 90cm Silicone Enteral Locking Feeding tube with orange radiopaque strip (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
34 | 10816340021462 | FTM6.5S-EL | 6.5Fr, 60cm Silicone Enteral Locking Feeding tube with orange radiopaque strip ( 6.5Fr, 60cm Silicone Enteral Locking Feeding tube with orange radiopaque strip (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
35 | 10816340021455 | FTS6.5S-EL | 6.5Fr, 40cm Silicone Enteral Locking Feeding tube with orange radiopaque strip ( 6.5Fr, 40cm Silicone Enteral Locking Feeding tube with orange radiopaque strip (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
36 | 10816340021448 | FTL5.0S-EL | 5.0Fr, 90cm Silicone Enteral Locking Feeding tube with orange radiopaque strip ( 5.0Fr, 90cm Silicone Enteral Locking Feeding tube with orange radiopaque strip (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
37 | 10816340021226 | FTS5.0S-EF | 5Fr, 40cm Silicone EnFit Feeding tube with orange radiopaque stripe (ISO 80369 5Fr, 40cm Silicone EnFit Feeding tube with orange radiopaque stripe (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
38 | 10816340021431 | FTM5.0S-EL | 5.0Fr, 60cm Silicone Enteral Locking Feeding tube with orange radiopaque strip ( 5.0Fr, 60cm Silicone Enteral Locking Feeding tube with orange radiopaque strip (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
39 | 10816340021424 | FTS5.0S-EL | 5.0Fr, 40cm Silicone Enteral Locking Feeding tube with orange radiopaque strip ( 5.0Fr, 40cm Silicone Enteral Locking Feeding tube with orange radiopaque strip (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
40 | 10816340021400 | FTM8.0P-EL | 8.0Fr, 60cm Polyurethene Enteral Locking Feeding tube with orange radiopaque str 8.0Fr, 60cm Polyurethene Enteral Locking Feeding tube with orange radiopaque strip (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
41 | 10816340021394 | FTS8.0P-EL | 8.0Fr, 50cm Polyurethene Enteral Locking Feeding tube with orange radiopaque str 8.0Fr, 50cm Polyurethene Enteral Locking Feeding tube with orange radiopaque strip (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
42 | 10816340021387 | FTL6.5P-EL | 6.5fr, 90cm Polyurethane Enteral Locking Feeding tube with orange radiopaque st 6.5fr, 90cm Polyurethane Enteral Locking Feeding tube with orange radiopaque strip (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
43 | 10816340021370 | FTM6.5P-EL | 6.5Fr, 60cm Polyurethane Enteral Locking Feeding tube with orange radiopaque str 6.5Fr, 60cm Polyurethane Enteral Locking Feeding tube with orange radiopaque strip (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
44 | 10816340021363 | FTS6.5P-EL | 6.5Fr, 40cm Polyurethane Enteral Locking Feeding tube with orange radiopaque str 6.5Fr, 40cm Polyurethane Enteral Locking Feeding tube with orange radiopaque strip (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
45 | 10816340021356 | FTL5.0P-EL | 5.0Fr, 90cm Polyurethane Enteral Locking Feeding tube with orange radiopaque str 5.0Fr, 90cm Polyurethane Enteral Locking Feeding tube with orange radiopaque strip (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
46 | 10816340021349 | FTM5.0P-EL | 5.0Fr, 60cm Polyurethane Enteral Locking Feeding tube with orange radiopaque str 5.0Fr, 60cm Polyurethane Enteral Locking Feeding tube with orange radiopaque strip (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
47 | 10816340021332 | FTS5.0P-EL | 5.0Fr, 40cm Polyurethane Enteral Locking Feeding tube with orange radiopaque str 5.0Fr, 40cm Polyurethane Enteral Locking Feeding tube with orange radiopaque strip (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
48 | 10816340021325 | FTM4.0P-EL | 4.0Fr, 60cm Polyurethane Enteral Locking Feeding tube with orange radiopaque str 4.0Fr, 60cm Polyurethane Enteral Locking Feeding tube with orange radiopaque strip (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. | |
49 | 10816340021318 | FTS4.0P-EL | 4.0Fr, 40cm Polyurethane Enteral Locking Feeding tube with orange radiopaque str 4.0Fr, 40cm Polyurethane Enteral Locking Feeding tube with orange radiopaque strip (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | NeoDevices, Inc. | ||
50 | 10816340021301 | FTL8.0S-EF | 8.0Fr, 90cm Silicone EnFit Feeding tube with orange radiopaque stripe (ISO 8036 8.0Fr, 90cm Silicone EnFit Feeding tube with orange radiopaque stripe (ISO 80369 compatible) | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | NeoDevices, Inc. |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B483EVN200000 | ENV-20000 | ENV-20000 | For full information, Envue System User Manual (6100-1) and IFU (6201-01)OVERVIE For full information, Envue System User Manual (6100-1) and IFU (6201-01)OVERVIEW OF SYSTEMThe ENvizion Medical ENvue System is an electromagnetic sensing device designed to aid qualified operators in the placement of the ENvizion Enteral Feeding Tube (EFT) into the stomach or small intestine of patients requiring enteral feeding. The ENvizion ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes, prior to commencing the delivery of enteral nutrition.Although this System has been designed to exacting specifications, it is not intended to replace trained personnel in the supervision of feeding tube placements. Only clinical personnel familiar with the placement of oro/nasoenteric tubes should perform tube placements.As placement is performed, the all-in-one PC displays the relative tip position and track. The entire placement is recorded and may be replayed later.The ENvizion Enteral Feeding Tube’s position must be confirmed per institution protocol (i.e., X- ray, pH measurement, etc.). 3. CONDITIONS FOR USE3.1. INDICATIONS FOR USEThe ENvizion Medical ENvue System is designed to aid qualified operators in the placement of the ENvizion Medical Enteral Feeding Tube of 8 Fr to 12 Fr into the stomach or small intestine of adult patients requiring enteral feeding. The ENvizion Medical ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes.The ENvizion Medical Enteral Feeding Tube (EFT) has been specifically designed for use with the ENvue System and is intended for placement in the stomach or small intestine. It is intended for use in adult patients who require intermittent or continuous feeding via the oro/nasoenteric route. The EFT is intended only to be used with a feeding pump and is not compatible with gravity-based feeding bags. | ENVue® System | ENVIZION MEDICAL LTD |
2 | B4831RSC011 | 1RSC01 | ENV-30000 | For full information, Envue System User Manual (6100-1) and IFU (6201-01)OVERVIE For full information, Envue System User Manual (6100-1) and IFU (6201-01)OVERVIEW OF SYSTEMThe ENvizion Medical ENvue System is an electromagnetic sensing device designed to aid qualified operators in the placement of the ENvizion Enteral Feeding Tube (EFT) into the stomach or small intestine of patients requiring enteral feeding. The ENvizion ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes, prior to commencing the delivery of enteral nutrition.Although this System has been designed to exacting specifications, it is not intended to replace trained personnel in the supervision of feeding tube placements. Only clinical personnel familiar with the placement of oro/nasoenteric tubes should perform tube placements.As placement is performed, the all-in-one PC displays the relative tip position and track. The entire placement is recorded and may be replayed later.The ENvizion Enteral Feeding Tube’s position must be confirmed per institution protocol (i.e., X- ray, pH measurement, etc.). 3. CONDITIONS FOR USE3.1. INDICATIONS FOR USEThe ENvizion Medical ENvue System is designed to aid qualified operators in the placement of the ENvizion Medical Enteral Feeding Tube of 8 Fr to 12 Fr into the stomach or small intestine of adult patients requiring enteral feeding. The ENvizion Medical ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes.The ENvizion Medical Enteral Feeding Tube (EFT) has been specifically designed for use with the ENvue System and is intended for placement in the stomach or small intestine. It is intended for use in adult patients who require intermittent or continuous feeding via the oro/nasoenteric route. The EFT is intended only to be used with a feeding pump and is not compatible with gravity-based feeding bags. | Reference Sensor Clip with Adhesive Patch for use with the ENVizion® ENVue® Syst | ENVIZION MEDICAL LTD |
3 | B48312EFT91S1 | 12EFT91S | ENV-12091 | 12 French Size, 91 cmFor full information, Envue System User Manual (6100-1) and 12 French Size, 91 cmFor full information, Envue System User Manual (6100-1) and IFU (6201-01)OVERVIEW OF SYSTEMThe ENvizion Medical ENvue System is an electromagnetic sensing device designed to aid qualified operators in the placement of the ENvizion Enteral Feeding Tube (EFT) into the stomach or small intestine of patients requiring enteral feeding. The ENvizion ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes, prior to commencing the delivery of enteral nutrition.Although this System has been designed to exacting specifications, it is not intended to replace trained personnel in the supervision of feeding tube placements. Only clinical personnel familiar with the placement of oro/nasoenteric tubes should perform tube placements.As placement is performed, the all-in-one PC displays the relative tip position and track. The entire placement is recorded and may be replayed later.The ENvizion Enteral Feeding Tube’s position must be confirmed per institution protocol (i.e., X- ray, pH measurement, etc.). 3. CONDITIONS FOR USE3.1. INDICATIONS FOR USEThe ENvizion Medical ENvue System is designed to aid qualified operators in the placement of the ENvizion Medical Enteral Feeding Tube of 8 Fr to 12 Fr into the stomach or small intestine of adult patients requiring enteral feeding. The ENvizion Medical ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes.The ENvizion Medical Enteral Feeding Tube (EFT) has been specifically designed for use with the ENvue System and is intended for placement in the stomach or small intestine. It is intended for use in adult patients who require intermittent or continuous feeding via the oro/nasoenteric route. The EFT is intended only to be used with a feeding pump and is not compatible with gravity-based feeding bags. | ENvue® Enteral Feeding Tube with Stylet and ENFit® Connector | ENVIZION MEDICAL LTD |
4 | B48312EFT140S1 | 12EFT140S | ENV-12140 | 12 French Size, 140 cmFor full information, Envue System User Manual (6100-1) an 12 French Size, 140 cmFor full information, Envue System User Manual (6100-1) and IFU (6201-01)OVERVIEW OF SYSTEMThe ENvizion Medical ENvue System is an electromagnetic sensing device designed to aid qualified operators in the placement of the ENvizion Enteral Feeding Tube (EFT) into the stomach or small intestine of patients requiring enteral feeding. The ENvizion ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes, prior to commencing the delivery of enteral nutrition.Although this System has been designed to exacting specifications, it is not intended to replace trained personnel in the supervision of feeding tube placements. Only clinical personnel familiar with the placement of oro/nasoenteric tubes should perform tube placements.As placement is performed, the all-in-one PC displays the relative tip position and track. The entire placement is recorded and may be replayed later.The ENvizion Enteral Feeding Tube’s position must be confirmed per institution protocol (i.e., X- ray, pH measurement, etc.). 3. CONDITIONS FOR USE3.1. INDICATIONS FOR USEThe ENvizion Medical ENvue System is designed to aid qualified operators in the placement of the ENvizion Medical Enteral Feeding Tube of 8 Fr to 12 Fr into the stomach or small intestine of adult patients requiring enteral feeding. The ENvizion Medical ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes.The ENvizion Medical Enteral Feeding Tube (EFT) has been specifically designed for use with the ENvue System and is intended for placement in the stomach or small intestine. It is intended for use in adult patients who require intermittent or continuous feeding via the oro/nasoenteric route. The EFT is intended only to be used with a feeding pump and is not compatible with gravity-based feeding bags. | ENvue® Enteral Feeding Tube with Stylet and ENFit® Connector | ENVIZION MEDICAL LTD |
5 | B48310EFT91S1 | 10EFT91S | ENV-10091 | 10 French units, 91 cmFor full information, Envue System User Manual (6100-1) an 10 French units, 91 cmFor full information, Envue System User Manual (6100-1) and IFU (6201-01)OVERVIEW OF SYSTEMThe ENvizion Medical ENvue System is an electromagnetic sensing device designed to aid qualified operators in the placement of the ENvizion Enteral Feeding Tube (EFT) into the stomach or small intestine of patients requiring enteral feeding. The ENvizion ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes, prior to commencing the delivery of enteral nutrition.Although this System has been designed to exacting specifications, it is not intended to replace trained personnel in the supervision of feeding tube placements. Only clinical personnel familiar with the placement of oro/nasoenteric tubes should perform tube placements.As placement is performed, the all-in-one PC displays the relative tip position and track. The entire placement is recorded and may be replayed later.The ENvizion Enteral Feeding Tube’s position must be confirmed per institution protocol (i.e., X- ray, pH measurement, etc.). 3. CONDITIONS FOR USE3.1. INDICATIONS FOR USEThe ENvizion Medical ENvue System is designed to aid qualified operators in the placement of the ENvizion Medical Enteral Feeding Tube of 8 Fr to 12 Fr into the stomach or small intestine of adult patients requiring enteral feeding. The ENvizion Medical ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes.The ENvizion Medical Enteral Feeding Tube (EFT) has been specifically designed for use with the ENvue System and is intended for placement in the stomach or small intestine. It is intended for use in adult patients who require intermittent or continuous feeding via the oro/nasoenteric route. The EFT is intended only to be used with a feeding pump and is not compatible with gravity-based feeding bags. | ENvue® Enteral Feeding Tube with Stylet and ENFit® Connector | ENVIZION MEDICAL LTD |
6 | B48310EFT140S1 | 10EFT140S | ENV-10140 | 10 French Size, 140 cmFor full information, Envue System User Manual (6100-1) an 10 French Size, 140 cmFor full information, Envue System User Manual (6100-1) and IFU (6201-01)OVERVIEW OF SYSTEMThe ENvizion Medical ENvue System is an electromagnetic sensing device designed to aid qualified operators in the placement of the ENvizion Enteral Feeding Tube (EFT) into the stomach or small intestine of patients requiring enteral feeding. The ENvizion ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes, prior to commencing the delivery of enteral nutrition.Although this System has been designed to exacting specifications, it is not intended to replace trained personnel in the supervision of feeding tube placements. Only clinical personnel familiar with the placement of oro/nasoenteric tubes should perform tube placements.As placement is performed, the all-in-one PC displays the relative tip position and track. The entire placement is recorded and may be replayed later.The ENvizion Enteral Feeding Tube’s position must be confirmed per institution protocol (i.e., X- ray, pH measurement, etc.). 3. CONDITIONS FOR USE3.1. INDICATIONS FOR USEThe ENvizion Medical ENvue System is designed to aid qualified operators in the placement of the ENvizion Medical Enteral Feeding Tube of 8 Fr to 12 Fr into the stomach or small intestine of adult patients requiring enteral feeding. The ENvizion Medical ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes.The ENvizion Medical Enteral Feeding Tube (EFT) has been specifically designed for use with the ENvue System and is intended for placement in the stomach or small intestine. It is intended for use in adult patients who require intermittent or continuous feeding via the oro/nasoenteric route. The EFT is intended only to be used with a feeding pump and is not compatible with gravity-based feeding bags. | ENvue® Enteral Feeding Tube with Stylet and ENFit® Connector | ENVIZION MEDICAL LTD |
7 | B48308EFT91S1 | ENV-08091 | ENV-08091 | 8 French Units, 91 cmFor full information, Envue System User Manual (6100-1) and 8 French Units, 91 cmFor full information, Envue System User Manual (6100-1) and IFU (6201-01)OVERVIEW OF SYSTEMThe ENvizion Medical ENvue System is an electromagnetic sensing device designed to aid qualified operators in the placement of the ENvizion Enteral Feeding Tube (EFT) into the stomach or small intestine of patients requiring enteral feeding. The ENvizion ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes, prior to commencing the delivery of enteral nutrition.Although this System has been designed to exacting specifications, it is not intended to replace trained personnel in the supervision of feeding tube placements. Only clinical personnel familiar with the placement of oro/nasoenteric tubes should perform tube placements.As placement is performed, the all-in-one PC displays the relative tip position and track. The entire placement is recorded and may be replayed later.The ENvizion Enteral Feeding Tube’s position must be confirmed per institution protocol (i.e., X- ray, pH measurement, etc.). 3. CONDITIONS FOR USE3.1. INDICATIONS FOR USEThe ENvizion Medical ENvue System is designed to aid qualified operators in the placement of the ENvizion Medical Enteral Feeding Tube of 8 Fr to 12 Fr into the stomach or small intestine of adult patients requiring enteral feeding. The ENvizion Medical ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes.The ENvizion Medical Enteral Feeding Tube (EFT) has been specifically designed for use with the ENvue System and is intended for placement in the stomach or small intestine. It is intended for use in adult patients who require intermittent or continuous feeding via the oro/nasoenteric route. The EFT is intended only to be used with a feeding pump and is not compatible with gravity-based feeding bags. | ENvue® Enteral Feeding Tube with Stylet and ENFit® Connector | ENVIZION MEDICAL LTD |
8 | 50884521020144 | 761610 | 761610 | Safety Single Pass PEG Kit,90 degree Bend, Pull | Kangaroo | CARDINAL HEALTH, INC. |
9 | 50884521001983 | 8884773600 | 8884773600 | Pump Set with Ice Pouch | Kangaroo | CARDINAL HEALTH, INC. |
10 | 40884521020178 | 762010 | 762010 | Safety Single Pass PEG Kit,90 degree Bend, Pull | Kangaroo | CARDINAL HEALTH, INC. |
11 | 40884521020161 | 762000 | 762000 | Safety Single Pass PEG Kit,Pull | Kangaroo | CARDINAL HEALTH, INC. |
12 | 40884521009654 | 8884730790 | 8884730790 | Pediatric Nasogastric Feeding Tube,Non-weighted, Dual Port Connector, No Stylet | Kangaroo | CARDINAL HEALTH, INC. |
13 | 40884521002013 | 8884773667 | 8884773667 | Pump Set | Kangaroo | CARDINAL HEALTH, INC. |
14 | 38054083008302 | 62903 | The AbbVie NJ is a 10 FR, 152 cm, naso-jejunal (NJ) tube made of white radiopaqu The AbbVie NJ is a 10 FR, 152 cm, naso-jejunal (NJ) tube made of white radiopaque polyurethane. The AbbVie NJ includes a silicone coated Stylet.The saleable unit (device count) is 1, there are 5 NJs in the saleable unit | AbbVie NJ | ABBVIE INC. | |
15 | 33660812074491 | 1015.002 | 1015.002 | C-GON Syringe for safety connection Nutrisafe 2 | VYGON | VYGON |
16 | 33660812073715 | 1015.352 | 1015.352 | C-GON Syringe for safety connection Nutrisafe 2 | VYGON | VYGON |
17 | 33660812053007 | 1022.102 | 1022.102 | Amber syringe for enteral drug administration | VYGON | VYGON |
18 | 33660812052994 | 1022.052 | 1022.052 | Amber syringe for enteral drug administration | VYGON | VYGON |
19 | 33660812052987 | 1022.022 | 1022.022 | Amber syringe for enteral drug administration | VYGON | VYGON |
20 | 33660812052970 | 1022.012 | 1022.012 | Amber syringe for enteral drug administration | VYGON | VYGON |
21 | 33660812040762 | 1015.212 | 1015.212 | C-GON Syringe for safety connection Nutrisafe 2 | VYGON | VYGON |
22 | 33660812034143 | 1015.602 | 1015.602 | C-GON Syringe for safety connection Nutrisafe 2 | VYGON | VYGON |
23 | 33660812033825 | 1015.102 | 1015.102 | C-GON Syringe for safety connection Nutrisafe 2 | VYGON | VYGON |
24 | 33660812033818 | 1015.202 | 1015.202 | C-GON Syringe for safety connection Nutrisafe 2 | VYGON | VYGON |
25 | 33660812033801 | 1015.052 | 1015.052 | C-GON Syringe for safety connection Nutrisafe 2 | VYGON | VYGON |
26 | 33660812033795 | 1015.022 | 1015.022 | C-GON Syringe for safety connection Nutrisafe 2 | VYGON | VYGON |
27 | 33660812033788 | 1015.012 | 1015.012 | C-GON Syringe for safety connection Nutrisafe 2 | VYGON | VYGON |
28 | 30884521664061 | 8884752042E | 8884752042E | Y-Port/PEG Adapter | Kangaroo | CARDINAL HEALTH, INC. |
29 | 30884521104017 | 8884752158 | 8884752158 | PEG Adapter | Kangaroo | CARDINAL HEALTH, INC. |
30 | 30884521104000 | 8884752141 | 8884752141 | PEG Adapter | Kangaroo | CARDINAL HEALTH, INC. |
31 | 30884521030941 | 8884761126 | 8884761126 | Bolus Feed Set | Kangaroo | CARDINAL HEALTH, INC. |
32 | 30884521026814 | 8884761118 | 8884761118 | Continuous Feed Set,Male | Kangaroo | CARDINAL HEALTH, INC. |
33 | 30884521026807 | 8884761100 | 8884761100 | Continuous Feed Set | Kangaroo | CARDINAL HEALTH, INC. |
34 | 30884521026791 | 8884742233 | 8884742233 | Gripstar Removal Device | Kangaroo | CARDINAL HEALTH, INC. |
35 | 30884521026784 | 8884742217 | 8884742217 | Obturator | Kangaroo | CARDINAL HEALTH, INC. |
36 | 30884521026777 | 8884742209 | 8884742209 | Obturator | Kangaroo | CARDINAL HEALTH, INC. |
37 | 30884521011650 | 8884741813 | 8884741813 | Skin Level Tube Access,Bolus Feeding Set | Kangaroo | CARDINAL HEALTH, INC. |
38 | 30884521011643 | 8884741805 | 8884741805 | Skin Level Stoma Measuring Device,Tube Access | Kangaroo | CARDINAL HEALTH, INC. |
39 | 30884521009664 | 8884752505 | 8884752505 | Naso-Jejunal Feeding Tube,7 g Weighted Tip | Kangaroo | CARDINAL HEALTH, INC. |
40 | 30884521009640 | 8884730782 | 8884730782 | Pediatric Nasogastric Feeding Tube,Weighted, No Stylet | Kangaroo | CARDINAL HEALTH, INC. |
41 | 30884521009633 | 8884730774 | 8884730774 | Pediatric Nasogastric Feeding Tube,Weighted, Dual Port Connector, No Stylet | Kangaroo | CARDINAL HEALTH, INC. |
42 | 30884521009626 | 8884730766 | 8884730766 | Pediatric Nasogastric Feeding Tube,Weighted with Stylet | Kangaroo | CARDINAL HEALTH, INC. |
43 | 30884521009619 | 8884730741 | 8884730741 | Pediatric Nasogastric Feeding Tube,Weighted with Stylet | Kangaroo | CARDINAL HEALTH, INC. |
44 | 30884521009602 | 8884730725 | 8884730725 | Pediatric Nasogastric Feeding Tube,Non-weighted, No Stylet | Kangaroo | CARDINAL HEALTH, INC. |
45 | 30884521009596 | 8884730717 | 8884730717 | Pediatric Nasogastric Feeding Tube,Non-weighted with Stylet | Kangaroo | CARDINAL HEALTH, INC. |
46 | 30884521009367 | 8884730709 | 8884730709 | Pediatric Nasogastric Feeding Tube,Non-weighted, Dual Port Connector, No Stylet | Kangaroo | CARDINAL HEALTH, INC. |
47 | 30884521007851 | 8884700744 | 8884700744 | Pediatric NG Tube Stylet | Kangaroo | CARDINAL HEALTH, INC. |
48 | 30884521007844 | 8884700702 | 8884700702 | Pediatric NG Tube Stylet | Kangaroo | CARDINAL HEALTH, INC. |
49 | 30884521007806 | 8884752208 | 8884752208 | PEG Obturator | Kangaroo | CARDINAL HEALTH, INC. |
50 | 30884521007462 | 8884750095 | 8884750095 | Jejunal Feeding and Gastric Decompression Tube | Kangaroo | CARDINAL HEALTH, INC. |