| 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 | 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 |
| 5 | 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. | 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 | 00827002564039 | G56403 | FLOW-20-PULL-SSK-S-T | FLOW 20 Percutaneous Endoscopic Gastrostomy Set - PULL | Flow 20 | COOK INCORPORATED |
| 2 | 00827002564022 | G56402 | PEG-24-PULL-SSK-S-T | PEG 24 Percutaneous Endoscopic Gastrostomy Set - Pull | PEG 24 | COOK INCORPORATED |
| 3 | 00827002519947 | G51994 | GDC-1400-30 | Gastric Drainage Catheter Set Ultrathane, | Cook | COOK INCORPORATED |
| 4 | 00827002519930 | G51993 | GDC-1400-53 | Gastric Drainage Catheter Set Ultrathane, | Cook | COOK INCORPORATED |
| 5 | 00827002504158 | G50415 | C-NJFT-14-U | Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube | Tiger | COOK INCORPORATED |
| 6 | 00827002496422 | G49642 | UFA-20-S | Universal Feeding Adapter | Cook | COOK INCORPORATED |
| 7 | 00827002496415 | G49641 | BFA-20-S | Bolus Feeding Adapter | Cook | COOK INCORPORATED |
| 8 | 00827002447868 | SBRD-24-ENF | 70-0060-224 | Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 24 FR | Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection | XERIDIEM MEDICAL DEVICES, INC. |
| 9 | 00827002447851 | SBRD-22-ENF | 70-0060-222 | Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 22 FR | Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection | XERIDIEM MEDICAL DEVICES, INC. |
| 10 | 00827002447844 | SBRD-20-ENF | 70-0060-220 | Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 20 FR | Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection | XERIDIEM MEDICAL DEVICES, INC. |
| 11 | 00827002447837 | SBRD-18-ENF | 70-0060-118 | Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 18 FR | Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection | XERIDIEM MEDICAL DEVICES, INC. |
| 12 | 00827002447820 | SBRD-16-ENF | 70-0060-116 | Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 16 FR | Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection | XERIDIEM MEDICAL DEVICES, INC. |
| 13 | 00827002447813 | SBRD-14-ENF | 70-0060-114 | Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 14 FR | Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection | XERIDIEM MEDICAL DEVICES, INC. |
| 14 | 00827002447806 | SBRD-12-ENF | 70-0060-112 | Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 12 FR | Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection | XERIDIEM MEDICAL DEVICES, INC. |
| 15 | 00827002363922 | G36392 | TDCS-100-M | Chait Trapdoor Cecostomy Catheter Set | Chait | COOK INCORPORATED |
| 16 | 00827002356986 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 22 FR/2.5cm | 70-0042-422 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 17 | 00827002356979 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 12 FR/1.5cm | 70-0042-212 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 18 | 00827002356962 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 24 FR/5.0cm | 70-0042-924 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 19 | 00827002356955 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 24 FR/4.5cm | 70-0042-824 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 20 | 00827002356948 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 24 FR/4.0cm | 70-0042-724 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 21 | 00827002356931 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 24 FR/3.5cm | 70-0042-624 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 22 | 00827002356924 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 24 FR/3.0cm | 70-0042-524 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 23 | 00827002356917 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 24 FR/2.5cm | 70-0042-424 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 24 | 00827002356900 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 24 FR/2.0cm | 70-0042-324 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 25 | 00827002356894 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 24 FR/1.5cm | 70-0042-224 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 26 | 00827002356887 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 22 FR/5.0cm | 70-0042-922 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 27 | 00827002356870 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 22 FR/4.5cm | 70-0042-822 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 28 | 00827002356863 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 22 FR/4.0cm | 70-0042-722 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 29 | 00827002356856 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 22 FR/3.5cm | 70-0042-622 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 30 | 00827002356849 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 22 FR/3.0cm | 70-0042-522 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 31 | 00827002356825 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 22 FR/2.0cm | 70-0042-322 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 32 | 00827002356818 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 22 FR/1.5cm | 70-0042-222 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 33 | 00827002356801 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 20 FR/5.0cm | 70-0042-920 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 34 | 00827002356795 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 20 FR/4.5cm | 70-0042-820 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 35 | 00827002356788 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 20 FR/4.0cm | 70-0042-720 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 36 | 00827002356771 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 20 FR/3.5cm | 70-0042-620 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 37 | 00827002356764 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 20 FR/3.0cm | 70-0042-520 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 38 | 00827002356757 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 20 FR/2.5cm | 70-0042-420 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 39 | 00827002356740 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 20 FR/2.0cm | 70-0042-320 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 40 | 00827002356733 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 20 FR/1.5cm | 70-0042-220 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 41 | 00827002356726 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 20 FR/1.0cm | 70-0042-120 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 42 | 00827002356719 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 20 FR/0.8cm | 70-0042-020 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 43 | 00827002356702 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 18 FR/5.0cm | 70-0042-918 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 44 | 00827002356696 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 18 FR/4.5cm | 70-0042-818 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 45 | 00827002356689 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 18 FR/4.0cm | 70-0042-718 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 46 | 00827002356672 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 18 FR/3.5cm | 70-0042-618 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 47 | 00827002356665 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 18 FR/3.0cm | 70-0042-518 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 48 | 00827002356658 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 18 FR/2.5cm | 70-0042-418 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 49 | 00827002356641 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 18 FR/2.0cm | 70-0042-318 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. | |
| 50 | 00827002356634 | EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 18 FR/1.5cm | 70-0042-218 | Entuit Thrive LP | XERIDIEM MEDICAL DEVICES, INC. |