| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00704411007442 | 1 | AS398 | AMSure® Sterile Normal Saline for Wound Flush devices are wound and device clean AMSure® Sterile Normal Saline for Wound Flush devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and fordevice irrigation. Sterile normal saline for wound flush are intended to be used in clinical and should only be used by clinicians familiar with the treatment of possiblecomplications. | FRO | Dressing, Wound, Drug | AMSure® Sterile Normal Saline for Wound Flush | |
| 2 | 00704411000986 | 1 | 435036118 | 3000ML RECEPTAL™ CANISTER | KDQ | Bottle, Collection, Vacuum | 2 | 3000ML RECEPTAL™ CANISTER |
| 3 | 40704411010334 | 1 | AS0552 | AMSure® Sterile Water for Inhalation, USP Prefilled Humidifier, 550mL | CAF | Nebulizer (Direct Patient Interface) | 2 | AMSure® Sterile Water for Inhalation, USP Prefilled Humidifier, 550mL |
| 4 | 40704411001325 | 1 | 443030420 | BRACKET CLAMP FOR ASAPTING WALL BRACKET TO FIT STANDS, CARTS OR IV POLES, STAINLESS STEEL | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | BRACKET CLAMP | |
| 5 | 40704411001257 | 1 | 434329211 | RECEPTAL™ TANDEM FLOOR STAND, STAINLESS STEEL WITH ROLLERS, CONDUCTIVE CASTERS | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | RECEPTAL™ TANDEM FLOOR STAND, STAINLESS STEEL WITH ROLLERS, CONDUCTIVE CASTERS |
| 6 | 40704411001240 | 1 | 434320411 | RECEPTAL™ TANDEM FLOOR STAND, STAINLESS STEEL WITH ROLLERS, CONDUCTIVE CASTERS | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | RECEPTAL™ TANDEM FLOOR STAND, STAINLESS STEEL WITH ROLLERS, CONDUCTIVE CASTERS |
| 7 | 40704411001233 | 1 | 434310401 | RECEPTAL™ SINGLE FLOOR STAND | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | RECEPTAL™ SINGLE FLOOR STAND |
| 8 | 40704411001172 | 1 | 434269215 | RECEPTAL™ SINGLE LONG CANISTER SUPPORT | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | RECEPTAL™ SINGLE LONG CANISTER SUPPORT | |
| 9 | 40704411001158 | 1 | 434260415 | RECEPTAL™ SINGLE LONG CANISTER SUPPORT | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | RECEPTAL™ SINGLE LONG CANISTER SUPPORT | |
| 10 | 40704411001127 | 1 | 434390401 | RECEPTAL™ TANDEM LONG 3L CANISTERS SUPPORT | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | RECEPTAL™ TANDEM LONG 3L CANISTERS SUPPORT |
| 11 | 40704411000700 | 1 | 434730415 | RECEPTAL™ DOUBLE 1/4 INCH(0.64CM) MALE TAPER | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | RECEPTAL™ DOUBLE 1/4 INCH(0.64CM) MALE TAPER | |
| 12 | 30704411010306 | 1 | ASR0059 | AMSure® Sodium Chloride Inhalation Solution, USP (0.9% NaCl), 5mL | CAF | Nebulizer (Direct Patient Interface) | 2 | AMSure® Sodium Chloride Inhalation Solution, USP (0.9% NaCl), 5mL |
| 13 | 30704411000314 | 1 | 432060411 | EZE-VAC® 2000ML DISPOSABLE SUCTION CANISTER | KDQ | Bottle, Collection, Vacuum | EZE-VAC® 2000ML DISPOSABLE SUCTION CANISTER | |
| 14 | 20704411004919 | 1 | 43010S9701 | RECEPTAL™ 1000ML LINER WITH VAC-GARD®, POUR SPOUT AND SOLIDIFIER | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | RECEPTAL™ 1000ML LINER WITH VAC-GARD®, POUR SPOUT AND SOLIDIFIER | |
| 15 | 20704411000188 | 1 | 430440415 | 2000ML RECEPTAL™ LINER WITH VAC-GARD® AND POUR SPOUT | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2000ML RECEPTAL™ LINER WITH VAC-GARD® AND POUR SPOUT | |
| 16 | 10704411014881 | 1 | AS89800 | 400mL Urine Meter attached to 2600mL Drainage Bag (China) with: Universal hook h 400mL Urine Meter attached to 2600mL Drainage Bag (China) with: Universal hook hangerBed sheet clampT-valve drainage outletAir ventAMSafe® needleless sampling port10 mL Pre-Filled Syringe with Sterile Water (China) | FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 2 | AMSure ® Add-A-Foley Tray |
| 17 | 10704411014706 | 1 | AS89830 | 400mL Urine Meter attached to 2600mL Drainage Bag (China) with: Universal hook h 400mL Urine Meter attached to 2600mL Drainage Bag (China) with: Universal hook hangerBed sheet clampT-valve drainage outletAir ventAMSafe® needleless sampling port30 mL Pre-Filled Syringe with Sterile Water (China) | FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 2 | AMSure ® Add-A-Foley Tray |
| 18 | 10704411010159 | 1 | AS115 | AMSure® Flat Top Piston Irrigation SyringeContents: • 1 Flat Top Piston Irrigati AMSure® Flat Top Piston Irrigation SyringeContents: • 1 Flat Top Piston Irrigation Syringe, 60ml/2oz • 1 Tip Protector • 1 Small Tube AdapterCaution: Proceed with irrigation procedure, using approved technique. | KYZ | Syringe, Irrigating (Non Dental) | 1 | AMSure® Flat Top Piston Irrigation Syringe |
| 19 | 10704411008460 | 1 | AS011P | AMSure® Bulb Irrigation SyringeCONTENTS:1 each Bulb Irrigation Syringe, 60 cc1 e AMSure® Bulb Irrigation SyringeCONTENTS:1 each Bulb Irrigation Syringe, 60 cc1 each Small Tube Adapter | KYZ | Syringe, Irrigating (Non Dental) | 1 | AMSure® Bulb Irrigation Syringe |
| 20 | 10704411008453 | 1 | AS011 | AMSure® Bulb Irrigation SyringeCONTENTS:1 each Bulb Irrigation Syringe, 60 ml1 e AMSure® Bulb Irrigation SyringeCONTENTS:1 each Bulb Irrigation Syringe, 60 ml1 each Tip Protector | KYZ | Syringe, Irrigating (Non Dental) | 1 | AMSure® Bulb Irrigation Syringe |
| 21 | 10704411008446 | 1 | AS010 | AMSure® Bulb Irrigation Syringe60ml, Catheter Tip with Tip Protector | KYZ | Syringe, Irrigating (Non Dental) | AMSure® Bulb Irrigation Syringe | |
| 22 | 10704411008415 | 1 | AS345 | AMSure® Specimen CupCONTENTS: 4 oz Graduated Cup with Screw Cap | NNI | Container, Specimen, Non-Sterile | AMSure® Specimen Cup | |
| 23 | 10704411007609 | 1 | AS870K | AMSure® Urethral Catheterization TrayCONTENTS STERILIZEDUSING ETHYLENE OXIDE:1 e AMSure® Urethral Catheterization TrayCONTENTS STERILIZEDUSING ETHYLENE OXIDE:1 each 14 Fr. Vinyl Catheter1 each 1000 mL Outer Basin Tray1 pair Vinyl Gloves1 each Waterproof Drape1 each Fenestrated Drape1 pack Lubricating Jelly1 each 4 oz Specimen CupNON-STERILE CONTENT:1 pack BZK Swabsticks (3) | FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 2 | AMSure® Urethral Catheterization Tray |
| 24 | 10704411007227 | 1 | AS861616C | AMSure® PVC Intermittent CatheterMale 16" Length Coude Tip | EZD | Catheter, Straight | 2 | AMSure® PVC Intermittent Catheter |
| 25 | 10704411007210 | 1 | AS861614C | AMSure® PVC Intermittent CatheterMale 16" Length Coude Tip | EZD | Catheter, Straight | 2 | AMSure® PVC Intermittent Catheter |
| 26 | 10704411007203 | 1 | AS861612C | AMSure® PVC Intermittent CatheterMale 16" Length Coude Tip | EZD | Catheter, Straight | 2 | AMSure® PVC Intermittent Catheter |
| 27 | 10704411007562 | 1 | AS85010K | AMSure® Urethral Self Catheterization Kit 10Fr.with • Pre-lubricated • Closed Sy AMSure® Urethral Self Catheterization Kit 10Fr.with • Pre-lubricated • Closed SystemCONTENTS STERILIZEDUSING ETHYLENE OXIDE:1 each Pre-lubricated PVC Urethral Catheter, 16” (40 cm) Length1 each 1100 mL Collection Bag with Insertion Tip1 each Waterproof Underpad, 13”x18” (340 x 450 mm)1 pair Cuffed Vinyl Gloves1 each Waste Disposal Bag1 each Gauze Pad, 4”x4”(100 x 100 mm)NON-STERILE CONTENTS:1 pack BZK Swabsticks (3)1 pack Benzalkonium Chloride Prep Pad | FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 2 | AMSure® Urethral Self Catheterization Kit 10Fr. |
| 28 | 10704411007197 | 1 | AS861610C | AMSure® PVC Intermittent CatheterMale 16" Length Coude Tip | EZD | Catheter, Straight | 2 | AMSure® PVC Intermittent Catheter |
| 29 | 10704411007500 | 1 | AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamberwith 7" attached extension set.One Split Septum Injection Site, One Needle-Free Injection Site, One Rotating Male Luer Lock AdapterLength=82”, Priming Volume=22mlNon-Pyrogenic fluid pathway. GRAVITY USE ONLY | FPA | Set, Administration, Intravascular | 2 | AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber | |
| 30 | 10704411007234 | 1 | AS861618C | AMSure® PVC Intermittent CatheterMale 16" Length Coude Tip | EZD | Catheter, Straight | 2 | AMSure® PVC Intermittent Catheter |
| 31 | 10704411005995 | 1 | WFM01FLT | MediChoice® Suction Canister Filter Reusable External Shut-Off Valve1 Each | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | MediChoice® Suction Canister Filter |
| 32 | 10704411005674 | 1 | MB4BR05 | AMSafe® 5 in. (13cm) MicroBore Bifurcated Ext. Setw/2 MicroClave, 2 removable cl AMSafe® 5 in. (13cm) MicroBore Bifurcated Ext. Setw/2 MicroClave, 2 removable clamps, Rotating Male luer Approx. Priming Volume 1.2 mL | FPA | Set, Administration, Intravascular | 2 | AMSafe® 5 in. (13cm) MicroBore Bifurcated Ext. Set |
| 33 | 10704411003663 | 1 | AS860618 | AMSure® PVC Intermittent CatheterFemale 6" Length | EZD | Catheter, Straight | 2 | AMSure® PVC Intermittent Catheter |
| 34 | 10704411003762 | 1 | AS861618 | AMSure® PVC Intermittent CatheterMale 16" Length | EZD | Catheter, Straight | 2 | AMSure® PVC Intermittent Catheter |
| 35 | 10704411004004 | 1 | AS961616 | AMSure® PVC Intermittent Catheterwith RPOLISHED® Eyes, Male 16" Length | EZD | Catheter, Straight | 2 | AMSure® PVC Intermittent Catheter |
| 36 | 10704411003755 | 1 | AS861616 | AMSure® PVC Intermittent CatheterMale 16" Length | EZD | Catheter, Straight | 2 | AMSure® PVC Intermittent Catheter |
| 37 | 10704411003922 | 1 | AS961006 | AMSure® PVC Intermittent Catheterwith RPOLISHED® Eyes, Pediatric 10" Length | EZD | Catheter, Straight | 2 | AMSure® PVC Intermittent Catheter |
| 38 | 10704411003656 | 1 | AS860616 | AMSure® PVC Intermittent CatheterFemale 6" Length | EZD | Catheter, Straight | 2 | AMSure® PVC Intermittent Catheter |
| 39 | 10704411004868 | 1 | MRSB-102 | AMSafe® 102" (259cm) Y-Type Blood Set w/210 Micron Filter, MicroClave® Clear, Ro AMSafe® 102" (259cm) Y-Type Blood Set w/210 Micron Filter, MicroClave® Clear, Rotating Luer, Approx Priming Volume: 20.2mL | FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 2 | AMSafe® 102" (259cm) Y-Type Blood Set |
| 40 | 10704411004844 | 1 | MRSA60E-88 | AMSafe® 88" (224cm) 60 Drop, Vented/Non-Vented Gravity Admin Set w/Pre-Slit Port AMSafe® 88" (224cm) 60 Drop, Vented/Non-Vented Gravity Admin Set w/Pre-Slit Port, 2 MicroClave® Clear, Rotating Luer, 1 Ext, Approx Priming Volume: 11.1mL | FMG | Stopcock, I.V. Set | 2 | AMSafe® 88" (224cm) 60 Drop, Vented/Non-Vented Gravity Admin Set |
| 41 | 10704411004820 | 1 | MRSA60E-104 | AMSafe® 104" (264cm) 60 Drop, Vented/Non-Vented Gravity Admin Set, 2 MicroClave® AMSafe® 104" (264cm) 60 Drop, Vented/Non-Vented Gravity Admin Set, 2 MicroClave® Clear, 2 Pre-Slit Ports, Rotating Luer, 1 Ext, Approx Priming Volume: 13.5mL | FMG | Stopcock, I.V. Set | 2 | AMSafe® 104" (264cm) 60 Drop, Vented/Non-Vented Gravity Admin Set |
| 42 | 10704411004516 | 1 | MB4V01 | AMSafe® MicroClave® multi-Dose vial Access spike, Approx Priming volume: 0.16mL | FPA | Set, Administration, Intravascular | 2 | AMSafe® MicroClave® multi-Dose vial Access spike |
| 43 | 10704411004141 | 1 | 433030411 | SPECIMEN TRAP 4 INCH (10 CM) POUR SPOUT COVERWITH 3/8 INCH (0.95 CM) COLLECTION SPECIMEN TRAP 4 INCH (10 CM) POUR SPOUT COVERWITH 3/8 INCH (0.95 CM) COLLECTION PORT, TETHERED CAP | GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | SPECIMEN TRAP 4 INCH (10 CM) POUR SPOUT COVER |
| 44 | 10704411003991 | 1 | AS961614 | AMSure® PVC Intermittent Catheterwith RPOLISHED® Eyes, Male 16" Length | EZD | Catheter, Straight | 2 | AMSure® PVC Intermittent Catheter |
| 45 | 10704411003694 | 1 | AS861010 | AMSure® PVC Intermittent CatheterPediatric 10" Length | EZD | Catheter, Straight | 2 | AMSure® PVC Intermittent Catheter |
| 46 | 10704411004073 | 1 | D38305 | AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamberwith 6" attached extension setNon-Pyrogenic fluid pathway. GRAVITY USE ONLY. Backcheck Valve. Two Split Septum Injection Sites. Two Needle-Free Injection Sites. One Rotating Male Luer Lock Adapter | FPA | Set, Administration, Intravascular | 2 | AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber |
| 47 | 10704411003984 | 1 | AS961612 | AMSure® PVC Intermittent Catheterwith RPOLISHED® Eyes, Male 16" Length | EZD | Catheter, Straight | 2 | AMSure® PVC Intermittent Catheter |
| 48 | 10704411004066 | 1 | D38304 | AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamberwith 12" attached extension setNon-Pyrogenic fluid pathway GRAVITY USE ONLY. Backcheck Valve. Two Split Septum Injection Sites. One Needle-Free Injection Site. One Rotating Male Luer Lock Adapter | FPA | Set, Administration, Intravascular | 2 | AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber |
| 49 | 10704411004059 | 1 | D38303 | AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamberwith 7" attached extension set.Non-Pyrogenic fluid pathway. GRAVITY USE ONLY. Backcheck Valve. One Split Septum Injection Site. One Needle-Free Injection Site. One Rotating Male Luer Lock Adapter | FPA | Set, Administration, Intravascular | 2 | AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber |
| 50 | 10704411004042 | 1 | D38302 | AMSafe-3 EXT6 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Ch AMSafe-3 EXT6 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamberwith 6" (152mm) attached extension set.Non-Pyrogenic fluid pathway. GRAVITY FEED ONLY. Two Split Septum Injection Sites. One Rotating Male Luer Lock Adapter. Two Needleless Injection Sites | FPA | Set, Administration, Intravascular | 2 | AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber |
| 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 |