| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 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. | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | Reference Sensor Clip with Adhesive Patch for use with the ENVizion® ENVue® Syst |
| 2 | 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. | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | ENVue® System |
| 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. | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | ENvue® Enteral Feeding Tube with Stylet and ENFit® Connector |
| 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. | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | ENvue® Enteral Feeding Tube with Stylet and ENFit® Connector |
| 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. | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | ENvue® Enteral Feeding Tube with Stylet and ENFit® Connector |
| 6 | 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. | KNT | Tubes, Gastrointestinal (And Accessories) | 2 | ENvue® Enteral Feeding Tube with Stylet and ENFit® Connector |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00817617022352 | 14762MS | Curaplex Nasogastric Tube, 18Fr 280ea/cs | Curaplex | BOUND TREE MEDICAL, LLC | |
| 2 | 00817617022345 | 14761 | Curaplex Nasogastric Tube, 16Fr 280ea/cs | Curaplex | BOUND TREE MEDICAL, LLC | |
| 3 | 00817617022338 | 14759 | Curaplex Nasogastric Tube, 14Fr 280ea/cs | Curaplex | BOUND TREE MEDICAL, LLC | |
| 4 | 00817617022321 | 14758MS | Curaplex Nasogastric Tube, 12Fr 280ea/cs | Curaplex | BOUND TREE MEDICAL, LLC | |
| 5 | 00817617022314 | 14757MS | Curaplex Nasogastric Tube, 10Fr 280ea/cs | Curaplex | BOUND TREE MEDICAL, LLC | |
| 6 | 00817617022307 | 14756MS | Curaplex Nasogastric Tube, 8Fr 280ea/cs | Curaplex | BOUND TREE MEDICAL, LLC | |
| 7 | 00817612020261 | 485 | 485 | The Dale ENFit ACE Connector is a plastic universal connector that provides in-l The Dale ENFit ACE Connector is a plastic universal connector that provides in-line feeding, suctioning, irrigation and medication while reducing the risk of potentially infectious splash back. The connector controls fluid flow into and out of most NG feeding tubes and other enteral tubes that use the ENFit connection system. The connector remains closed to the atmosphere, reducing the risk of cross contamination and eliminates mess and formula loss by maintaining a closed system (no disconnect). It has a simple ON/OFF handle and built in Needleless Syringe Port Seal which accepts most ENFit tip syringes. It is designed to physically prevent the administration of enteral formula into an I.V. line and is incompatible with luer connectors. The ENFit ACE Connector is DEHP free and not made with natural latex rubber. | Dale ENFit ACE Connector | DALE MEDICAL PRODUCTS, INC. |
| 8 | 00817612020247 | 475 | 475 | The Dale ACE Connector is a plastic universal connector that provides in-line fe The Dale ACE Connector is a plastic universal connector that provides in-line feeding, suctioning, irrigation and medication delivery while reducing the risk of potentially infectious splash back. The connector controls fluid flow into and out of most NG feeding tubes and other enteral tubes. The connector remains closed to the atmosphere, reducing the risk of cross contamination and eliminates mess and formula loss by maintaining a closed system (no disconnect). It has a simple ON/OFF handle and built in Needleless Syringe Port Seal which accepts most catheter tip 60 ml syringes. It is designed to physically prevent the administration of enteral formula into an I.V. line and is incompatible with luer connectors. The ACE Connector is DEHP free and not made with natural rubber latex. | Dale ACE Connector | DALE MEDICAL PRODUCTS, INC. |
| 9 | 00817584013322 | PEXT-3STBNC | PEXT-3STNC | NeoConnect 3" (8 cm) Large Bore Sampling Straw with ENFit Connector, Purple | NeoConnect Straw | NEOMED, INC. |
| 10 | 00817584013315 | EXT-3STBNC | EXT-3STNC | NeoConnect 3" (8 cm) Large Bore Sampling Straw with ENFit Connector, Orange | NeoConnect Straw | NEOMED, INC. |
| 11 | 00817584013049 | PNM-40ENENB | PNM-40ENENB | 40" (102 cm) PVC Enteral Extension Set, Enteral Only, Large Bore, Purple | NeoMed Enteral Extension Set | NEOMED, INC. |
| 12 | 00817584013001 | PEXT-40BNC | PEXT-40BNC | 40" (102cm) PVC Enteral Extension Set with ENFit Connector, Large Bore, Purple | NeoMed NeoConnect Enteral Extension Sets | NEOMED, INC. |
| 13 | 00817584012998 | EXT-40BNC | EXT-40BNC | 40" (102cm) PVC Enteral Extension Set with ENFit Connector, Large Bore | NeoMed NeoConnect Enteral Extension Sets | NEOMED, INC. |
| 14 | 00817584012974 | EXT-30BNC | EXT-30BNC | 30” Extra-Large Bore Enteral Extension Set with ENFit Connector, Orange | NeoMed NeoConnect Enteral Extension Sets | NEOMED, INC. |
| 15 | 00817584012967 | PEXT-30NC | PEXT-30NC | NeoConnect 30” (76 cm) Enteral Extension Set with ENFit Connector, Purple | NeoMed NeoConnect Enteral Extension Sets | NEOMED, INC. |
| 16 | 00817584012943 | PNM-18ENENB | PNM-18ENENB | 18" (46 cm) Enteral Extension Set with Clamp, Large Bore, Purple | NeoMed Enteral Extension Set | NEOMED, INC. |
| 17 | 00817584012936 | NM-30ENEN | NM-30ENEN | 30" (76 cm) non-DEHP PVC Enteral Extension Set, Enteral Only | NeoMed Enteral Extension Set | NEOMED, INC. |
| 18 | 00817584012899 | PNM-48ENENB | PNM-48ENENB | 48" (122 cm) PVC Enteral Extension Set, Enteral Only, Large Bore, Purple | NeoMed Enteral Extension Set | NEOMED, INC. |
| 19 | 00817584012882 | PNM-60ENENY | PNM-60ENENY | 60" (152 cm) Bifurcated, PVC Enteral Extension Set, Enteral Only, Purple | NeoMed Enteral Extension Set | NEOMED, INC. |
| 20 | 00817584012875 | PNM-60ENEN | PNM-60ENEN | 60" (152 cm) non-DEHP PVC Enteral Extension Set, Enteral Only, Purple | NeoMed Enteral Extension Set | NEOMED, INC. |
| 21 | 00817584012745 | PFTL8.0V-EO | PFTL8.0V-EO | PVC Feeding Tube, 8.0 Fr x 90 cm, EO, Purple | NeoMed Enteral Feeding Tube | NEOMED, INC. |
| 22 | 00817584012738 | PFTM8.0V-EO | PFTM8.0V-EO | PVC Feeding Tube, 8.0 Fr x 60 cm, EO, Purple | NeoMed Enteral Feeding Tube | NEOMED, INC. |
| 23 | 00817584012721 | PFTS8.0V-EO | PFTS8.0V-EO | PVC Feeding Tube, 8.0 Fr x 40 cm, EO, Purple | NeoMed Enteral Feeding Tube | NEOMED, INC. |
| 24 | 00817584012714 | PFTL5.0V-EO | PFTL5.0V-EO | PVC Feeding Tube, 5.0 Fr x 90 cm, EO, Purple | NeoMed Enteral Feeding Tube | NEOMED, INC. |
| 25 | 00817584012707 | PFTM5.0V-EO | PFTM5.0V-EO | PVC Feeding Tube, 5.0 Fr x 60 cm, EO, Purple | NeoMed Enteral Feeding Tube | NEOMED, INC. |
| 26 | 00817584012691 | PFTS5.0V-EO | PFTS5.0V-EO | PVC Feeding Tube, 5.0 Fr x 40 cm, EO, Purple | NeoMed Enteral Feeding Tube | NEOMED, INC. |
| 27 | 00817584012684 | FTL8.0V-EO | FTL8.0V-EO | PVC Feeding Tube, 8.0 Fr x 90 cm, EO | NeoMed Enteral Feeding Tube | NEOMED, INC. |
| 28 | 00817584012677 | FTM8.0V-EO | FTM8.0V-EO | PVC Feeding Tube, 8.0 Fr x 60 cm, EO | NeoMed Enteral Feeding Tube | NEOMED, INC. |
| 29 | 00817584012660 | FTS8.0V-EO | FTS8.0V-EO | PVC Feeding Tube, 8.0 Fr x 40 cm, EO | NeoMed Enteral Feeding Tube | NEOMED, INC. |
| 30 | 00817584012653 | FTL5.0V-EO | FTL5.0V-EO | PVC Feeding Tube, 5.0 Fr x 90 cm, EO | NeoMed Enteral Feeding Tube | NEOMED, INC. |
| 31 | 00817584012646 | FTM5.0V-EO | FTM5.0V-EO | PVC Feeding Tube, 5.0 Fr x 60 cm, EO | NeoMed Enteral Feeding Tube | NEOMED, INC. |
| 32 | 00817584012639 | FTS5.0V-EO | FTS5.0V-EO | PVC Feeding Tube, 5.0 Fr x 40 cm, EO | NeoMed Enteral Feeding Tube | NEOMED, INC. |
| 33 | 00817584012622 | PFTL6.5V-EO | PFTL6.5V-EO | PVC Feeding Tube, 6.0 Fr x 90 cm, EO, Purple | NeoMed Enteral Feeding Tube | NEOMED, INC. |
| 34 | 00817584012615 | PFTM6.5V-EO | PFTM6.5V-EO | PVC Feeding Tube, 6.5 Fr x 60 cm, EO, Purple | NeoMed Enteral Feeding Tube | NEOMED, INC. |
| 35 | 00817584012608 | PFTS6.5V-EO | PFTS6.5V-EO | PVC Feeding Tube, 6.0 Fr x 40 cm, EO, Purple | NeoMed Enteral Feeding Tube | NEOMED, INC. |
| 36 | 00817584012080 | PEXT-6STBNC | PEXT-6STBNC | 6" Large Bore Sampling Straw with ENFit Connector, Purple | NeoConnect Straw | NEOMED, INC. |
| 37 | 00817584012073 | PEXT-3STNC | PEXT-3STNC | NeoConnect 3" (8 cm) Sampling Straw with ENFit Connector, Purple | NeoConnect Straw | NEOMED, INC. |
| 38 | 00817584012066 | EXT-6STBNC | EXT-6STBNC | 6" Large Bore Sampling Straw with ENFit Connector, Orange | NeoConnect Straw | NEOMED, INC. |
| 39 | 00817584012059 | EXT-3STNC | EXT-3STNC | NeoConnect 3" (8 cm) Sampling Straw with ENFit Connector, Orange | NeoConnect Straw | NEOMED, INC. |
| 40 | 00817584012042 | PEXT-60YNC | PEXT-60YNC | 60" Bifurcated Enteral Extension Set with ENFit Connector, Purple | NeoConnect Enteral Extension Set | NEOMED, INC. |
| 41 | 00817584012035 | EXT-60YNC | EXT-60YNC | 60" Bifurcated Enteral Extension Set with ENFit Connector, Orange | NeoConnect Enteral Extension Set | NEOMED, INC. |
| 42 | 00817584012028 | PEXT-60NC | PEXT-60NC | NeoConnect 60" (152 cm) Enteral Extension Set with ENFit Connector, Purple | NeoConnect Enteral Extension Set | NEOMED, INC. |
| 43 | 00817584012011 | EXT-60NC | EXT-60NC | NeoConnect 60" (152 cm) Enteral Extension Set with ENFit Connector, Orange | NeoConnect Enteral Extension Set | NEOMED, INC. |
| 44 | 00817584012004 | PEXT-48BNC | PEXT-48BNC | 48" Large Bore Enteral Extension Set with ENFit Connector, Purple | NeoConnect Enteral Extension Set | NEOMED, INC. |
| 45 | 00817584011991 | EXT-48BNC | EXT-48BNC | 48" Large Bore Enteral Extension Set with ENFit Connector, Orange | NeoConnect Enteral Extension Set | NEOMED, INC. |
| 46 | 00817584011984 | PEXT-18BNC | PEXT-18BNC | 18" Extra-Large Bore Enteral Extension Set with ENFit Connector, Purple | NeoConnect Enteral Extension Set | NEOMED, INC. |
| 47 | 00817584011977 | EXT-18BNC | EXT-18BNC | 18" Extra-Large Bore Enteral Extension Set with ENFit Connector, Orange | NeoConnect Enteral Extension Set | NEOMED, INC. |
| 48 | 00817584011960 | PEXT-30BNC | PEXT-30BNC | 30” Extra-Large Bore Enteral Extension Set with ENFit Connector, Purple | NeoConnect Enteral Extension Set | NEOMED, INC. |
| 49 | 00817584011953 | EXT-30NC | EXT-30NC | NeoConnect 30” (76 cm) Enteral Extension Set with ENFit Connector, Orange | NeoConnect Enteral Extension Set | NEOMED, INC. |
| 50 | 00817584011946 | PEXT-8YNC | PEXT-8YNC | 8" Bifurcated Enteral Extension Set with ENFit Connector, Purple | NeoConnect Enteral Extension Set | NEOMED, INC. |