No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00813502010848 | 42FR Sewing Cuff Assessory | 0507-0042 | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
2 | 00813502010831 | 32FR Sewing Cuff Assessory | 0507-0032 | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
3 | 00813502010817 | Cannula Kit 12mm/42 Apical (Sil) | 0506-1242-SV | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
4 | 00813502010800 | Cannula Kit 12mm/42 Atrial (Sil) | 0506-1242-SA | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
5 | 00813502010794 | Cannula Kit 10mm/42 Apical (Hem) | 0506-1042-HV | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
6 | 00813502010787 | Cannula Kit 10mm/42 Atrial (Hem) | 0506-1042-HA | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
7 | 00813502010770 | Cannula Kit 12mm/32 Apical (Sil) | 0506-1232-SV | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
8 | 00813502010763 | Cannula Kit 12mm/32 Atrial (Sil) | 0506-1232-SA | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
9 | 00813502010756 | Cannula Kit 10mm/32 Apical (Hem) | 0506-1032-HV | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
10 | 00813502010749 | Cannula Kit 10mm/32 Atrial (Hem) | 0506-1032-HA | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
11 | 00813502010732 | 42FR VENT/ATR CANN PKGD BOXED | 0506-0042M-VA | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
12 | 00813502010725 | ASSY,BXD, CA 42FR,S APIC W/SH | 0506-0042MS-SA | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
13 | 00813502010718 | 42FR ATERIAL CANNULA, PRODUCT | 0506-0042-AR | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
14 | 00813502010701 | 32FR VENT/ATR CANN PKGD BOXED | 0506-0032M-VA | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
15 | 00813502010695 | ASSY,BOXD,CAN 32FR S APIC W/SH | 0506-0032MS-SA | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
16 | 00813502010688 | 10mm Sil Art Cann Boxed | 0506-0010-SIL | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
17 | 00813502010671 | 10mm Hemashield Art Cannula | 0506-0010-HAR | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
18 | 00813502010404 | AB Pump Set 12mm/42 Apical (Sil) | 0055-1242-SV | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
19 | 00813502010398 | AB Pump Set 12mm/42 Atrial (Sil) | 0055-1242-SA | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
20 | 00813502010381 | AB Pump Set 12mm/32 Apical (Sil) | 0055-1232-SV | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
21 | 00813502010374 | AB Pump Set 12mm/32 Atrial (Sil) | 0055-1232-SA | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
22 | 00813502010367 | AB Pump Set 10mm/42 Apical (Sil) | 0055-0042-SV | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
23 | 00813502010350 | AB Pump Set 10mm/42 Atrial (Sil) | 0055-1042-SA | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
24 | 00813502010343 | AB Pump Set 10mm/42 Apical (Hem) | 005-1042-HV | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
25 | 00813502010336 | AB Pump Set 10mm/42x2 Atrial (Hem) | 005-1042-HAA | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
26 | 00813502010329 | AB Pump Set 10mm/42 Atrial (Hem) | 005-1042-HA | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
27 | 00813502010312 | AB Pump Set 10mm/32 Apical (Sil) | 0055-1032-SV | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
28 | 00813502010305 | AB Pump Set 10mm/32 Atrial (Sil) | 0055-1032-SA | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
29 | 00813502010299 | AB Pump Set 10mm/32 Apical (Hem) | 055-1032-HV | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
30 | 00813502010282 | AB Pump Set 10mm/32x2 Atrial (Hem) | 005-1032-HAA | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
31 | 00813502010275 | AB Pump Set 10mm/32 Atrial (Hem) | 0055-1032-HA | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
32 | 00813502010268 | AB Vent Set. 42F V/A & 10mm | 005-0042-MH | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
33 | 00813502010251 | AB Vent Set, 32FR V/A & 10MM | 005-0032-MH | Ventricular (Assist) Bypass | DSQ | Ventricular (Assisst) Bypass | 3 | AB5000 |
34 | 00813502011791 | ABMD 23Fr X 30cm Introducer Kit | 0052-3069 | DYB | Introducer, Catheter | 2 | Impella® 23F x 30cm Sheath | |
35 | 00813502011784 | Kit, 23Fr Axillary Introducer, 6cm, ABMD | 0052-3068 | Impella® 23F x 6cm Axillary Sheath | ||||
36 | 00813502011715 | ABMD Introducer Kit, 14Fr x Long, Pkgd | 0052-0039 | ABMD Introducer Kit, 14Fr x Long, Pkgd | DYB | Introducer, Catheter | 2 | Impella |
37 | 00813502011661 | KIT, 14Fr INTRODUCER, 25 cm, ABMD | 00523058 | KIT, 14Fr INTRODUCER, 25 cm, ABMD | DYB | Introducer, Catheter | 2 | Impella |
38 | 00813502011654 | KIT, 14Fr INTRODUCER, 13 cm, ABMD | 00523057 | KIT, 14Fr INTRODUCER, 13 cm, ABMD | DYB | Introducer, Catheter | 2 | Impella |
39 | 00813502011531 | Impella 5.5 with SmartAssist Set, US | 0550-0008 | Temporary non-roller type left heart support blood pump | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | 3 | Impella |
40 | 00813502011500 | KIT, 14Fr INTRODUCER, 13&25 cm, ABMD | 0052356 | KIT, 14Fr INTRODUCER, 13&25 cm, ABMD | DYB | Introducer, Catheter | 2 | Impella |
41 | 00813502011371 | Impella CP with SmartAssist | 0048-0024 | Temporary non-roller type left heart support blood pump | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | 3 | Impella |
42 | 00813502011364 | Impella 2.5 13 FR OEM Introducer Kit | OZD,DYB | Temporary Non-Roller Type Left Heart Support Blood Pump,Introducer, Catheter | 2 | Impella | ||
43 | 00813502011319 | Impella OEM 23 FR Introducer kit | 0052-0002 | Temporary cardiac support blood pump | DYB,OZD | Introducer, Catheter,Temporary Non-Roller Type Left Heart Support Blood Pump | 2 | Impella |
44 | 00813502011302 | Impella CP 14 FR Introducer Kit | OZD,DYB | Temporary Non-Roller Type Left Heart Support Blood Pump,Introducer, Catheter | 2 | Impella | ||
45 | 00813502011289 | Impella CP Pump Set | 0048-0003.0814 | Temporary cardiac support blood pump | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | 3 | Impella |
46 | 00813502011258 | Impella CP Pump Set | 0048-0003.0814 | Temporary cardiac support blood pump | OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | 3 | Impella |
47 | 00813502011227 | Impella LD AIC Pump Set | 005082 | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 2 | Impella |
48 | 00813502011210 | Impella LD Pump Set | 004683 | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 2 | Impella |
49 | 00813502011180 | Impella 5.0 AIC Pump Set | 005062 | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM,OZD | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type,Temporary Non-Roller Type C Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type,Temporary Non-Roller Type Cardiac Support Blood Pump | 2 | Impella |
50 | 00813502011173 | Impella 5.0 MPC Pump Set | 004683 | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 2 | Impella |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00850004312032 | SS085075L | PN1008533-003 | The Steerable introducer sheath consists of a steerable sheath connected to a ha The Steerable introducer sheath consists of a steerable sheath connected to a handle with steering controls, a hemostasis valve with sideport featuring a 3-way stopcock, and a tapered dilator. The device is provided sterile in a sealed tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire, with size compatibility as indicated on the product labels. A dilator hub is provided with a female luer tapered fitting for flushing. The device includes a side port with stopcock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration. The device usable length, lumen length, outer diameter, curl size, and inner diameter/tool compatibility specifications are indicated on the product labels. The distal end of the sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device. | Steerable Introducer Sheath 8.5F Large Curl | FREUDENBERG MEDICAL, LLC |
2 | 00850004312025 | SS085075M | PN1008533-002 | The Steerable introducer sheath consists of a steerable sheath connected to a ha The Steerable introducer sheath consists of a steerable sheath connected to a handle with steering controls, a hemostasis valve with sideport featuring a 3-way stopcock, and a tapered dilator. The device is provided sterile in a sealed tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire, with size compatibility as indicated on the product labels. A dilator hub is provided with a female luer tapered fitting for flushing. The device includes a side port with stopcock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration. The device usable length, lumen length, outer diameter, curl size, and inner diameter/tool compatibility specifications are indicated on the product labels. The distal end of the sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device. | Steerable Introducer Sheath 8.5F Medium Curl | FREUDENBERG MEDICAL, LLC |
3 | 00850004312018 | SS085075S | PN1008533-001 | The Steerable introducer sheath consists of a steerable sheath connected to a ha The Steerable introducer sheath consists of a steerable sheath connected to a handle with steering controls, a hemostasis valve with sideport featuring a 3-way stopcock, and a tapered dilator. The device is provided sterile in a sealed tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire, with size compatibility as indicated on the product labels. A dilator hub is provided with a female luer tapered fitting for flushing. The device includes a side port with stopcock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration. The device usable length, lumen length, outer diameter, curl size, and inner diameter/tool compatibility specifications are indicated on the product labels. The distal end of the sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device. | Steerable Introducer Sheath 8.5F Small Curl | FREUDENBERG MEDICAL, LLC |
4 | 00850004312001 | 668782-100 | PN1007960-100 | The EMPOWER™ Introducer Sheath with Hydrophilic Coating consists of a single-use The EMPOWER™ Introducer Sheath with Hydrophilic Coating consists of a single-use disposable introducer sheath and dilator that is inserted into the peripheral vasculature to support the introduction of diagnostic or interventional devices, while minimizing blood loss associated with such insertions. The EMPOWER™ Introducer Sheath is coil-reinforced and coated with a lubricious hydrophilic coating. The EMPOWER™ hemostasis valve is integrated into the sheath hub and features a variable aperture seal for enhanced control over device insertion while maintaining hemostasis. The valve is normally closed until the user squeezes the actuator levers to proportionally open the valve and receive any device up to its labeled size. A sideport extends from the EMPOWER™ valve housing with a 3-way stopcock.The radiopaque dilator is designed to accommodate an .035” (0.89mm) guidewire and includes a proximal hub grip with a female luer taper fitting for flushing. Prior to insertion, the dilator hub can be secured to the EMPOWER™ housing with a quarter-turn twist. | EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING | FREUDENBERG MEDICAL, LLC |
5 | 00850004162200 | VGHIS04 | VGHIS04 | VGHIS04 INTRODUCER SET | INTRODUCER SET | VALFLUX GROUP, LLC |
6 | 00850004162194 | VGHIS03 | VGHIS03 | VGHIS03 INTRODUCER SET | INTRODUCER SET | VALFLUX GROUP, LLC |
7 | 00850004162187 | VGHIS02 | VGHIS02 | VGHIS02 INTRODUCER SET | INTRODUCER SET | VALFLUX GROUP, LLC |
8 | 00850004162170 | VGHIS01 | VGHIS01 | VGHIS01 INTRODUCER SET | INTRODUCER SET | VALFLUX GROUP, LLC |
9 | 00850004162163 | VGHIS00 | VGHIS00 | VGHIS00 INTRODUCER SET | INTRODUCER SET | VALFLUX GROUP, LLC |
10 | 00850004162156 | VGCTR04A | VGCTR04A | VGCTR04A INTRODUCER SET | INTRODUCER SET | VALFLUX GROUP, LLC |
11 | 00850004162149 | VGCTR04 | VGCTR04 | VGCTR04 INTRODUCER SET | INTRODUCER SET | VALFLUX GROUP, LLC |
12 | 00850004162132 | VGCTR03A | VGCTR03A | VGCTR03A INTRODUCER SET | INTRODUCER SET | VALFLUX GROUP, LLC |
13 | 00850004162125 | VGCTR03 | VGCTR03 | VGCTR03 INTRODUCER SET | INTRODUCER SET | VALFLUX GROUP, LLC |
14 | 00849884004311 | VYAA21G7S | VYAA21G7S | 21GA SAFETY NEEDLE, 7CM | VYGON | VYGON CORPORATION |
15 | 00849884004304 | VYAA21G7 | VYAA21G7 | 21GA. X 7CM INTRODUCER NEEDLE | VYGON | VYGON CORPORATION |
16 | 00849884004298 | VYAA21G4S | VYAA21G4S | 21GA SAFETY NEEDLE, 4CM | VYGON | VYGON CORPORATION |
17 | 00849884004281 | VYAA21G4 | VYAA21G4 | 21GA. X 4CM INTRODUCER NEEDLE | VYGON | VYGON CORPORATION |
18 | 00849884004274 | VYAA21G2 | VYAA21G2 | 21GA. X 2.5CM INTRODUCER NEEDLE | VYGON | VYGON CORPORATION |
19 | 00849884004267 | VY-NDL3F | VY-NDL3F | 3FR FLARED NEEDLE | VYGON | VYGON CORPORATION |
20 | 00849884004250 | VAT6007 | VAT6007 | 6F X 7CM PTFE TEARAWAY INTRODUCER | VYGON | VYGON CORPORATION |
21 | 00849884004243 | VAT5510 | VAT5510 | 5.5F X 10CM PTFE TEARAWAY INTRODUCER | VYGON | VYGON CORPORATION |
22 | 00849884004236 | VAT5507 | VAT5507 | 5.5F X 7CM PTFE TEARAWAY INTRODUCER | VYGON | VYGON CORPORATION |
23 | 00849884004229 | VAT4510 | VAT4510 | 4.5F X 10CM PTFE TEARAWAY INTRODUCER | VYGON | VYGON CORPORATION |
24 | 00849884004212 | VAT4007 | VAT4007 | 4.0F X 7CM PTFE TEARAWAY INTRODUCER | VYGON | VYGON CORPORATION |
25 | 00849884004205 | VAT3005 | VAT3005 | 3.5F X 5CM PTFE TEARAWAY INTRODUCER | VYGON | VYGON CORPORATION |
26 | 00849884002362 | 1262.30N | 1262.30N | 20 GA. SPLITTING INTRODUCER NEEDLE | VYGON | VYGON CORPORATION |
27 | 00849884002041 | 7371.19 | 7371.19 | MICROFLASH INTRODUCER 2FR | VYGON | VYGON CORPORATION |
28 | 00846835012388 | D140010 | D140010 | Bi-Directional Guiding Sheath, Small Curve | MobiCath™ | GREATBATCH LTD |
29 | 00846835012371 | D140011 | D140011 | MobiCath BiDirectional Guiding Sheath, Large Curve | MobiCath™ | GREATBATCH LTD |
30 | 00841268109780 | INT-128-17 | INT-128-17 | Tearaway Introducer Set | Tearaway Introducer Set | GALT MEDICAL CORP. |
31 | 00841268109773 | INT-128-16 | INT-128-16 | Tearaway Introducer Set | Tearaway Introducer Set | GALT MEDICAL CORP. |
32 | 00841268109766 | INT-128-15 | INT-128-15 | Tearaway Introducer Set | Tearaway Introducer Set | GALT MEDICAL CORP. |
33 | 00841268109759 | INT-128-04 | INT-128-04 | Tearaway Introducer Set | Tearaway Introducer Set | GALT MEDICAL CORP. |
34 | 00841268109742 | INT-128-03 | INT-128-03 | Tearaway Introducer Set | Tearaway Introducer Set | GALT MEDICAL CORP. |
35 | 00841268109735 | INT-128-02 | INT-128-02 | Tearaway Introducer Set | Tearaway Introducer Set | GALT MEDICAL CORP. |
36 | 00841268109728 | INT-128-01 | INT-128-01 | Tearaway Introducer Set | Tearaway Introducer Set | GALT MEDICAL CORP. |
37 | 00841268109643 | INT-117-16 | INT-117-16 | Tearaway Sheath Introducer | Tearaway Sheath Introducer | GALT MEDICAL CORP. |
38 | 00841268109599 | INT-116-16 | INT-116-16 | Tearaway Introducer Set | Tearaway Introducer Set | GALT MEDICAL CORP. |
39 | 00841268109582 | CLI-115-16 | CLI-115-16 | Elite HV® F Introducer Kit | Elite HV® F Introducer Kit | GALT MEDICAL CORP. |
40 | 00841268109575 | CLI-115-15 | CLI-115-15 | Elite HV® F Introducer Kit | Elite HV® F Introducer Kit | GALT MEDICAL CORP. |
41 | 00841268109568 | CLI-115-14 | CLI-115-14 | Elite HV® F Introducer Kit | Elite HV® F Introducer Kit | GALT MEDICAL CORP. |
42 | 00841268109551 | CLI-115-07 | CLI-115-07 | Elite HV® F Introducer Kit | Elite HV® F Introducer Kit | GALT MEDICAL CORP. |
43 | 00841268109544 | CLI-114-16 | CLI-114-16 | Elite HV® F Introducer Kit | Elite HV® F Introducer Kit | GALT MEDICAL CORP. |
44 | 00841268109537 | CLI-114-15 | CLI-114-15 | Elite HV® F Introducer Kit | Elite HV® F Introducer Kit | GALT MEDICAL CORP. |
45 | 00841268109520 | CLI-114-07 | CLI-114-07 | Elite HV® F Introducer Kit | Elite HV® F Introducer Kit | GALT MEDICAL CORP. |
46 | 00841268109513 | CLI-113-16 | CLI-113-16 | Elite HV® F Introducer Kit | Elite HV® F Introducer Kit | GALT MEDICAL CORP. |
47 | 00841268109506 | CLI-113-15 | CLI-113-15 | Elite HV® F Introducer Kit | Elite HV® F Introducer Kit | GALT MEDICAL CORP. |
48 | 00841268109490 | CLI-113-07 | CLI-113-07 | Elite HV® F Introducer Kit | Elite HV® F Introducer Kit | GALT MEDICAL CORP. |
49 | 00841268109483 | CLI-102-41 | CLI-102-41 | Elite HV® F Introducer Kit | Elite HV Introducer Set | GALT MEDICAL CORP. |
50 | 00841268109469 | DIL-501-21 | DIL-501-21 | Dilator | Dilator | GALT MEDICAL CORP. |