| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00815277026727 | 38006 | Curaplex Endotracheal Tube with Stylette, 5.0mm, Uncuffed 10ea/bx 10bx/cs | BTR | Tube, tracheal (w/wo connector) | 2 | Curaplex | |
| 2 | 00815277026697 | 38005 | Curaplex Endotracheal Tube with Stylette, 4.5mm, Uncuffed 10ea/bx 10bx/cs | BTR | Tube, tracheal (w/wo connector) | Curaplex | ||
| 3 | 00817617022567 | 2113-10335 | Curaplex Select Endotracheal Tube with Stylette, 3.5mm, Uncuffed 10ea/bx 10bx/cs | BTR | Tube, tracheal (w/wo connector) | Curaplex | ||
| 4 | 00817617022550 | 2113-10330 | Curaplex Select Endotracheal Tube with Stylette, 3.0mm, Uncuffed 10ea/bx 10bx/cs | BTR | Tube, tracheal (w/wo connector) | Curaplex | ||
| 5 | 00817617022543 | 2113-10290 | Curaplex Select Endotracheal Tube with Stylette, 9.0mm, Cuffed 10ea/bx 10bx/cs | BTR | Tube, tracheal (w/wo connector) | 2 | Curaplex | |
| 6 | 00817617022536 | 2113-10285 | Curaplex Select Endotracheal Tube with Stylette, 8.5mm, Cuffed 10ea/bx 10bx/cs | BTR | Tube, tracheal (w/wo connector) | 2 | Curaplex | |
| 7 | 00817617022529 | 2113-10280 | Curaplex Select Endotracheal Tube with Stylette, 8.0mm, Cuffed 10ea/bx 10bx/cs | BTR | Tube, tracheal (w/wo connector) | 2 | Curaplex | |
| 8 | 00817617022512 | 2113-10275 | Curaplex Select Endotracheal Tube with Stylette, 7.5mm, Cuffed 10ea/bx 10bx/cs | BTR | Tube, tracheal (w/wo connector) | Curaplex | ||
| 9 | 00817617022505 | 2113-10270 | Curaplex Select Endotracheal Tube with Stylette, 7.0mm, Cuffed 10ea/bx 10bx/cs | BTR | Tube, tracheal (w/wo connector) | Curaplex | ||
| 10 | 00817617022499 | 2113-10265 | Curaplex Select Endotracheal Tube with Stylette, 6.5mm, Cuffed 10ea/bx 10bx/cs | BTR | Tube, tracheal (w/wo connector) | Curaplex | ||
| 11 | 00817617022482 | 2113-10255 | Curaplex Select Endotracheal Tube with Stylette, 5.5mm, Cuffed 10ea/bx 10bx/cs | BTR | Tube, tracheal (w/wo connector) | Curaplex | ||
| 12 | 00817617022475 | 2113-10250 | Curaplex Select Endotracheal Tube with Stylette, 5.0mm, Cuffed 10ea/bx 10bx/cs | BTR | Tube, tracheal (w/wo connector) | 2 | Curaplex | |
| 13 | 00817617022468 | 2113-10245 | Curaplex Select Endotracheal Tube with Stylette, 4.5mm, Cuffed 10ea/bx 10bx/cs | BTR | Tube, tracheal (w/wo connector) | 2 | Curaplex | |
| 14 | 00817617022451 | 2113-10235 | Curaplex Select Endotracheal Tube with Stylette, 3.5mm, Cuffed 10ea/bx 10bx/cs | BTR | Tube, tracheal (w/wo connector) | Curaplex | ||
| 15 | 00817617022444 | 1612-84245 | IV Catheter, ClearSafe Comfort, 20 ga x 1 in, Safety 50ea/bx 4bx/cs | FOZ | Catheter,intravascular,therapeutic,short-term less than 30 days | Curaplex | ||
| 16 | 00817617022437 | 1612-84240 | IV Catheter, ClearSafe Comfort, 20 ga x 1 1/4 in, Safety 50ea/bx 4bx/cs | FOZ | Catheter,intravascular,therapeutic,short-term less than 30 days | 2 | Curaplex | |
| 17 | 00817617022420 | 1612-84230 | IV Catheter, ClearSafe Comfort, 18 ga x 1 1/4 in, Safety 50ea/bx 4bx/cs | FOZ | Catheter,intravascular,therapeutic,short-term less than 30 days | 2 | Curaplex | |
| 18 | 00817617022413 | 1612-84220 | IV Catheter, ClearSafe Comfort, 16 ga x 1 1/4 in, Safety 50ea/bx 4bx/cs | FOZ | Catheter,intravascular,therapeutic,short-term less than 30 days | Curaplex | ||
| 19 | 00817617022406 | 1612-84160 | IV Catheter, ClearSafe, 24 ga x 3/4 in, Safety 50ea/bx 4bx/cs | FOZ | Catheter,intravascular,therapeutic,short-term less than 30 days | 2 | Curaplex | |
| 20 | 00817617022390 | 1612-84150 | IV Catheter, ClearSafe, 22 ga x 1 in, Safety 50ea/bx 4bx/cs | FOZ | Catheter,intravascular,therapeutic,short-term less than 30 days | 2 | Curaplex | |
| 21 | 00815277027687 | 660223 | BASIC TRAUMA KIT - US EMBASSY | HEB,GAR,NBW,MMK,BTM,FMF,DXQ,MHC,DQA,POQ,FRO,FOZ | TAMPON, MENSTRUAL, UNSCENTED,Suture, nonabsorbable, synthetic, polyamide,SYSTEM, TAMPON, MENSTRUAL, UNSCENTED,Suture, nonabsorbable, synthetic, polyamide,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Container, sharps,Ventilator, emergency, manual (resuscitator),Syringe, piston,blood pressure cuff,PORT, INTRAOSSEOUS, IMPLANTED,Oximeter,Blood transfusion kit,Dressing, wound, drug,Catheter,intravascular,therapeutic,short-term less than 30 days | 2 | Curaplex | |
| 22 | 00817617022383 | 1612-84145 | IV Catheter, ClearSafe, 20 ga x 1 in, Safety 50ea/bx 4bx/cs | FOZ | Catheter,intravascular,therapeutic,short-term less than 30 days | 2 | Curaplex | |
| 23 | 00815277027670 | 660205 | Curaplex 8.5 Intubation Kit | OGK | Orotrachael intubation guide kit | 2 | Curaplex | |
| 24 | 00817617022376 | 1612-84140 | IV Catheter, ClearSafe, 20 ga x 1 1/4 in, Safety 50ea/bx 4bx/cs | FOZ | Catheter,intravascular,therapeutic,short-term less than 30 days | Curaplex | ||
| 25 | 00817617022369 | 1612-84130 | IV Catheter, ClearSafe, 18 ga x 1 1/4 in, Safety 50ea/bx 4bx/cs | FOZ | Catheter,intravascular,therapeutic,short-term less than 30 days | 2 | Curaplex | |
| 26 | 00817617022352 | 14762MS | Curaplex Nasogastric Tube, 18Fr 280ea/cs | KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | Curaplex | ||
| 27 | 00817617022345 | 14761 | Curaplex Nasogastric Tube, 16Fr 280ea/cs | KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | Curaplex | ||
| 28 | 00817617022338 | 14759 | Curaplex Nasogastric Tube, 14Fr 280ea/cs | KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | Curaplex | ||
| 29 | 00817617022321 | 14758MS | Curaplex Nasogastric Tube, 12Fr 280ea/cs | KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | Curaplex | ||
| 30 | 00817617022314 | 14757MS | Curaplex Nasogastric Tube, 10Fr 280ea/cs | KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | Curaplex | ||
| 31 | 00817617022307 | 14756MS | Curaplex Nasogastric Tube, 8Fr 280ea/cs | KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | Curaplex | ||
| 32 | 00815277027663 | 660204 | Curaplex 8.0 Intubation Kit | OGK | Orotrachael intubation guide kit | 2 | Curaplex | |
| 33 | 00817617022291 | 12992 | Curaplex Infra-Red Ear Thermometer 20ea/cs | FLL | Thermometer, electronic, clinical | 2 | Curaplex | |
| 34 | 00817617021386 | 8600-01181 | *Custom* City of Joliet Chest Decompression Kit | FOZ,KDQ | Catheter,intravascular,therapeutic,short-term less than 30 days,BOTTLE, COLLECTION, VACUUM | 2 | Curaplex | |
| 35 | 00817617021379 | 8600-01112 | *Custom* NY IFAK | OHO | First aid kit without drug | 1 | Curaplex | |
| 36 | 00817617021362 | 670006-KIT | Kit, DHS IFAK- Oakland | OHO | First aid kit without drug | 1 | Curaplex | |
| 37 | 00817617021355 | 662157 | Curaplex Officer Vehicle Trauma Kit | OHO | First aid kit without drug | 1 | Curaplex | |
| 38 | 00815277027465 | 2525-36703 | KIT, RAPID RESPONSE AIR - RRAK | OGI,BZT,CCK,CAN,DQA,OGH,LNZ,KGB | Nasal endotracheal tube holder kit,STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL COND Nasal endotracheal tube holder kit,STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS,ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE,REGULATOR, PRESSURE, GAS CYLINDER,Oximeter,Laryngoscope kit,Changer, tube, endotracheal,MASK, OXYGEN, NON-REBREATHING | 1 | Curaplex | |
| 39 | 00815277021036 | 4267C | Kit Contents Only For Curaplex Deluxe Responder Kit 684267C | DXQ,CBP | blood pressure cuff,Valve, non-rebreathing | 2 | Curaplex | |
| 40 | 00815277021029 | 382000RC | Curaplex Kit Responder Red | CAN,DXQ,CBP | REGULATOR, PRESSURE, GAS CYLINDER,blood pressure cuff,Valve, non-rebreathing | 1 | Curaplex | |
| 41 | 00815277027052 | 38017 | Curaplex Endotracheal Tube with Stylette, 8.0mm, Cuffed 10ea/bx 10bx/cs | BTR | Tube, tracheal (w/wo connector) | Curaplex | ||
| 42 | 00815277021012 | 382000OC | Curaplex Kit Responder Orange | CAN,CBP,DXQ | REGULATOR, PRESSURE, GAS CYLINDER,Valve, non-rebreathing,blood pressure cuff | 1 | Curaplex | |
| 43 | 00815277027021 | 38016 | Curaplex Endotracheal Tube with Stylette, 7.5mm, Cuffed 10ea/bx 10bx/cs | BTR | Tube, tracheal (w/wo connector) | Curaplex | ||
| 44 | 00815277026994 | 38015 | Curaplex Endotracheal Tube with Stylette, 7.0mm, Cuffed 10ea/bx 10bx/cs | BTR | Tube, tracheal (w/wo connector) | 2 | Curaplex | |
| 45 | 00815277021005 | 382000GC | Curaplex Kit Responder Green | CAN,DXQ,CBP | REGULATOR, PRESSURE, GAS CYLINDER,blood pressure cuff,Valve, non-rebreathing | 1 | Curaplex | |
| 46 | 00815277026963 | 38014 | Curaplex Endotracheal Tube with Stylette, 6.5mm, Cuffed 10ea/bx 10bx/cs | BTR | Tube, tracheal (w/wo connector) | 2 | Curaplex | |
| 47 | 00815277026932 | 38013 | Curaplex Endotracheal Tube with Stylette, 6.0mm, Cuffed 10ea/bx 10bx/cs | BTR | Tube, tracheal (w/wo connector) | Curaplex | ||
| 48 | 00815277025720 | 36045 | Curaplex CPR Pocketmask w/O2 inlet 100ea/cs | CBP | Valve, non-rebreathing | 2 | Curaplex | |
| 49 | 00815277020992 | 382000BC | Curaplex Kit Responder Blue | CBP,CAN,DXQ | Valve, non-rebreathing,REGULATOR, PRESSURE, GAS CYLINDER,blood pressure cuff | 1 | Curaplex | |
| 50 | 00815277026901 | 38012 | Curaplex Endotracheal Tube with Stylette, 5.5mm, Cuffed 10ea/bx 10bx/cs | BTR | Tube, tracheal (w/wo connector) | Curaplex |
| 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 |