| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00610075205196 | 11026 | Intermittent catheter, 10 Fr 16 in, Coude | GBM | CATHETER, URETHRAL | Apogee IC | ||
| 2 | 00610075068586 | 11026Q | Urethral Intermittent Catheter, Coudé Tip | GBM | CATHETER, URETHRAL | Apogee | ||
| 3 | 00610075037773 | 3777 | Premie One-Piece Ostomy Pouch – Flat Cut-to-Fit Barrier_15mm 5/8" | EXB | COLLECTOR, OSTOMY | Pouchkins | ||
| 4 | 20610075177480 | B8FB | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Firm, Kit, 8 Fr 16 in, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 5 | 20610075177473 | B8F | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Firm, 8 Fr 16 in, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 6 | 20610075177466 | B6FB | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 6 Fr 16 in, Firm, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 7 | 20610075177442 | B18FB | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 18 Fr 16 in, Firm, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 8 | 20610075177435 | B18F | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 18 Fr 16 in, Firm, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 9 | 20610075177428 | B16RB | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 16 Fr 16 in, Latex, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 10 | 20610075177411 | B16R | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 16 Fr 16 in, Latex, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 11 | 20610075177381 | B16CB | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 16 Fr 16 in, Coude | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 12 | 20610075177374 | B16C | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 16 Fr 16 in, Coude | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 13 | 20610075177343 | B14RB | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 14 Fr 16 in, Latex, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 14 | 00610075037780 | 3778 | Newborn One-Piece Ostomy Pouch – Flat Cut-to-Fit Barrier_35x22mm 1-3/8x7/8" | EXB | COLLECTOR, OSTOMY | Pouchkins | ||
| 15 | 20610075177336 | B14R | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 14 Fr 16 in, Latex, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 16 | 20610075177312 | B14FBUS | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 14 Fr 16 in, Firm, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 17 | 20610075177305 | B14CB | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 14 Fr 16 in, Coude | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 18 | 20610075177299 | B14C | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 14 Fr 16 in, Coude | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 19 | 20610075177268 | B12RB | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 12 Fr 16 in, Latex, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 20 | 20610075177220 | B12CB | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 12 Fr 16 in, Coude | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 21 | 20610075177213 | B12C | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 12 Fr 16 in, Coude | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 22 | 20610075177206 | B10FB | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, Firm, 10 Fr 16 in, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 23 | 20610075177190 | B10F | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Firm, 10 Fr 16 in, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 24 | 20610075177183 | B16FB | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 16 Fr 16 in, Firm, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 25 | 20610075177176 | B16F | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 16 Fr 16 in, Firm, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 26 | 20610075177169 | B14SB | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 14 Fr 16 in, Soft, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 27 | 20610075177152 | B14S | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 14 Fr 16 in, Soft, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 28 | 20610075177145 | B14F-FEMALE | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Firm, 14 Fr 8 in, Female, Firm, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 29 | 20610075177138 | B14FB-FEMALE | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 14 Fr 8 in, Female, Firm, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 30 | 20610075177121 | B14FB | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 14 Fr 16 in, Firm, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 31 | 20610075177114 | B14F | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 14 Fr 16 in, Firm, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 32 | 20610075177107 | B12SB | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 12 Fr 16 in, Soft, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 33 | 20610075177091 | B12S | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 12 Fr 16 in, Soft, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 34 | 20610075177084 | B12FB | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 12 Fr 16 in, Firm, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 35 | 20610075177077 | B12F | Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 12 Fr 16 in, Firm, Straight | KOD | CATHETER, UROLOGICAL | Apogee Plus | ||
| 36 | 00610075205172 | 11010 | Intermittent catheter, 10 Fr 10 in, Straight | GBM | CATHETER, URETHRAL | Apogee IC | ||
| 37 | 00610075205165 | 11006 | Intermittent catheter, 10 Fr 6 in, Straight | GBM | CATHETER, URETHRAL | Apogee IC | ||
| 38 | 00610075205158 | 10826 | Intermittent catheter, 8 Fr 16 in, Coude | GBM | CATHETER, URETHRAL | Apogee IC | ||
| 39 | 00610075205141 | 10816 | Intermittent catheter, 8 Fr 16 in, Straight | GBM | CATHETER, URETHRAL | Apogee IC | ||
| 40 | 00610075205134 | 10810 | Intermittent catheter, 8 Fr 10 in, Straight | GBM | CATHETER, URETHRAL | Apogee IC | ||
| 41 | 00610075205127 | 10806 | Intermittent catheter, 8 Fr 6 in, Straight | GBM | CATHETER, URETHRAL | Apogee IC | ||
| 42 | 00610075205110 | 10616 | Intermittent catheter, 6 Fr 16 in, Straight | GBM | CATHETER, URETHRAL | Apogee IC | ||
| 43 | 00610075205103 | 10610 | Intermittent catheter, 6 Fr 10 in, Straight | GBM | CATHETER, URETHRAL | Apogee IC | ||
| 44 | 00610075179657 | 32007 | Bowel Catheter System, Disposable Kit | KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | 2 | ActiFlo | |
| 45 | 00610075179640 | 32006 | Bowel Catheter System, Disposable Kit | KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | 2 | ActiFlo | |
| 46 | 00610075179626 | 32004 | Bowel Catheter System, Drainable Kit | KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | 2 | ActiFlo | |
| 47 | 00610075097821 | 9782 | Vertical tube attachment device - Accommodates 5Fr to 40Fr tubes | KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | Hollister | ||
| 48 | 00610075097807 | 9780 | Drain tube attachment device - Accommodates 10Fr to 24Fr tubes | KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | Hollister | ||
| 49 | 00610075097791 | 9779 | Universal Catheter Access Port | EXB | COLLECTOR, OSTOMY | Hollister | ||
| 50 | 00610075097784 | 9778 | Wound Drainage Collector with Barrier | GDS | BAG, STOMAL | Hollister |
| 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 | 30884521664061 | 8884752042E | 8884752042E | Y-Port/PEG Adapter | Kangaroo | CARDINAL HEALTH, INC. |
| 16 | 30884521104017 | 8884752158 | 8884752158 | PEG Adapter | Kangaroo | CARDINAL HEALTH, INC. |
| 17 | 30884521104000 | 8884752141 | 8884752141 | PEG Adapter | Kangaroo | CARDINAL HEALTH, INC. |
| 18 | 30884521030941 | 8884761126 | 8884761126 | Bolus Feed Set | Kangaroo | CARDINAL HEALTH, INC. |
| 19 | 30884521026814 | 8884761118 | 8884761118 | Continuous Feed Set,Male | Kangaroo | CARDINAL HEALTH, INC. |
| 20 | 30884521026807 | 8884761100 | 8884761100 | Continuous Feed Set | Kangaroo | CARDINAL HEALTH, INC. |
| 21 | 30884521026791 | 8884742233 | 8884742233 | Gripstar Removal Device | Kangaroo | CARDINAL HEALTH, INC. |
| 22 | 30884521026784 | 8884742217 | 8884742217 | Obturator | Kangaroo | CARDINAL HEALTH, INC. |
| 23 | 30884521026777 | 8884742209 | 8884742209 | Obturator | Kangaroo | CARDINAL HEALTH, INC. |
| 24 | 30884521011650 | 8884741813 | 8884741813 | Skin Level Tube Access,Bolus Feeding Set | Kangaroo | CARDINAL HEALTH, INC. |
| 25 | 30884521011643 | 8884741805 | 8884741805 | Skin Level Stoma Measuring Device,Tube Access | Kangaroo | CARDINAL HEALTH, INC. |
| 26 | 30884521009664 | 8884752505 | 8884752505 | Naso-Jejunal Feeding Tube,7 g Weighted Tip | Kangaroo | CARDINAL HEALTH, INC. |
| 27 | 30884521009640 | 8884730782 | 8884730782 | Pediatric Nasogastric Feeding Tube,Weighted, No Stylet | Kangaroo | CARDINAL HEALTH, INC. |
| 28 | 30884521009633 | 8884730774 | 8884730774 | Pediatric Nasogastric Feeding Tube,Weighted, Dual Port Connector, No Stylet | Kangaroo | CARDINAL HEALTH, INC. |
| 29 | 30884521009626 | 8884730766 | 8884730766 | Pediatric Nasogastric Feeding Tube,Weighted with Stylet | Kangaroo | CARDINAL HEALTH, INC. |
| 30 | 30884521009619 | 8884730741 | 8884730741 | Pediatric Nasogastric Feeding Tube,Weighted with Stylet | Kangaroo | CARDINAL HEALTH, INC. |
| 31 | 30884521009602 | 8884730725 | 8884730725 | Pediatric Nasogastric Feeding Tube,Non-weighted, No Stylet | Kangaroo | CARDINAL HEALTH, INC. |
| 32 | 30884521009596 | 8884730717 | 8884730717 | Pediatric Nasogastric Feeding Tube,Non-weighted with Stylet | Kangaroo | CARDINAL HEALTH, INC. |
| 33 | 30884521009367 | 8884730709 | 8884730709 | Pediatric Nasogastric Feeding Tube,Non-weighted, Dual Port Connector, No Stylet | Kangaroo | CARDINAL HEALTH, INC. |
| 34 | 30884521007851 | 8884700744 | 8884700744 | Pediatric NG Tube Stylet | Kangaroo | CARDINAL HEALTH, INC. |
| 35 | 30884521007844 | 8884700702 | 8884700702 | Pediatric NG Tube Stylet | Kangaroo | CARDINAL HEALTH, INC. |
| 36 | 30884521007806 | 8884752208 | 8884752208 | PEG Obturator | Kangaroo | CARDINAL HEALTH, INC. |
| 37 | 30884521007462 | 8884750095 | 8884750095 | Jejunal Feeding and Gastric Decompression Tube | Kangaroo | CARDINAL HEALTH, INC. |
| 38 | 30884521003839 | 8888261800 | 8888261800 | Polyurethane Feeding Tube,Radiopaque Line | Kangaroo | CARDINAL HEALTH, INC. |
| 39 | 30884521003815 | 8888261503 | 8888261503 | Polyurethane Feeding Tube,Radiopaque Line | Kangaroo | CARDINAL HEALTH, INC. |
| 40 | 30884521003761 | 8888261206 | 8888261206 | PVC Feeding Tube with Radiopaque Line | Argyle | CARDINAL HEALTH, INC. |
| 41 | 30884521003617 | 8888260802 | 8888260802 | PVC Feeding Tube with Radiopaque Line | Argyle | CARDINAL HEALTH, INC. |
| 42 | 30884521003235 | 8888260604 | 8888260604 | PVC Feeding Tube with Radiopaque Line | Argyle | CARDINAL HEALTH, INC. |
| 43 | 30884521003211 | 8888260208 | 8888260208 | PVC Feeding Tube with Radiopaque Line | Argyle | CARDINAL HEALTH, INC. |
| 44 | 30884521001552 | 8884706212 | 8884706212 | Rigid Container Pump Set,No Tubing | Kangaroo | CARDINAL HEALTH, INC. |
| 45 | 30884521000951 | 8884702005 | 8884702005 | Pump Set Bag | Kangaroo | CARDINAL HEALTH, INC. |
| 46 | 30884521000272 | 777702 | 777702 | CO2 Detector with Bellows | Kangaroo | CARDINAL HEALTH, INC. |
| 47 | 30849884005180 | 1015.352M-NS | 1015.352M-NS | NUTRISAFE2 35mL SYRINGE | VYGON | VYGON CORPORATION |
| 48 | 30849884005173 | 1015.602M-NS | 1015.602M-NS | NUTRISAFE2 60mL SYRINGE | VYGON | VYGON CORPORATION |
| 49 | 30849884005166 | 1015.122M-NS | 1015.122M-NS | NUTRISAFE2 12mL SYRINGE | VYGON | VYGON CORPORATION |
| 50 | 30849884002240 | 1022.002 | 1022.002 | BULK AMBER NS2 SYRINGE 0.5ML | VYGON | VYGON CORPORATION |