No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00856571007258 | 10009-2 | 10009-2 | Archimedes Planning Software is software installed on a laptop computer used for Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue. | LLZ | System, Image Processing, Radiological | 2 | Archimedes Access Key, 10-pack |
2 | 00856571007241 | 10010 | 10010 | The EMPOWER RF Catheter is a monopolar endoscopic tool that is used to deliver c The EMPOWER RF Catheter is a monopolar endoscopic tool that is used to deliver controlled radiofrequency (RF) energy to a target site within the upper airway or tracheobronchial tree when connected to a standard electrosurgical generator. The EMPOWER RF Catheter is inserted through the bronchoscope/extended working channel of 2.0 mm ID or greater to reach the target site. | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Empower RF Catheter |
3 | 00856571007012 | 10005-1 | 10005-1 | Single use coring needle for retrieval of tissue samples. It is placed through Single use coring needle for retrieval of tissue samples. It is placed through a flexible bronchoscope. | EOQ | Bronchoscope (Flexible Or Rigid) | 2 | FleXNeedle |
4 | 00856571007296 | 10009-9 | 10009-9 | A collection of sterile devices designed to access and perform a biopsy sample d A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy. w/o Syringe | EOQ | Bronchoscope (Flexible Or Rigid) | 2 | Archimedes Access Kit |
5 | 00856571007128 | 30009 | 30009 | LungPoint Planning Software is software installed on a laptop computer used for LungPoint Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue. | LLZ | System, Image Processing, Radiological | 2 | LungPoint Planning System, v3.2 |
6 | 00856571007067 | 10007 | 10007 | A sterile single use flexible tube that provides a working channel during a bron A sterile single use flexible tube that provides a working channel during a bronchoscopic procedure through which other devices may be introduced to the targeted area within the respiratory organs. The sheath is advanced through the working channel of a bronchoscope and allows for the repeated placement of endoscopic devices to a specified lesion(s) during a procedure. | EOQ | Bronchoscope (Flexible Or Rigid) | 2 | Archimedes Sheath |
7 | 00856571007029 | 10009 | 10009 | A collection of sterile devices designed to access and perform a biopsy sample d A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy. | EOQ | Bronchoscope (Flexible Or Rigid) | 2 | Archimedes Access Kit |
8 | 00856571007036 | 40005 | 40005 | Archimedes software is installed on a desktop computer used to plan procedures a Archimedes software is installed on a desktop computer used to plan procedures and navigate to targets in the lung. The Procedure Module offers real-time navigation guidance for use during the bronchoscopy procedure. The Software provides the option to segment previously acquired CT or other DICOM data sets and overlay and register these segmented data sets onto live fluoroscopic X-ray images. The software allows visualization of the bronchial tree; helps guide the tools in or adjacent to the bronchial tree; allows visualization of a predefined target in lung tissue; and assists with placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery. | LLZ | System, Image Processing, Radiological | 2 | Archimedes System |
9 | 00856571007210 | 10005-2 | 10005-2 | Single use coring needle for retrieval of tissue samples. It is placed through Single use coring needle for retrieval of tissue samples. It is placed through a flexible bronchoscope. | EOQ | Bronchoscope (Flexible Or Rigid) | 2 | FleXNeedle (5 pack) |
10 | 00856571007227 | 10009-1 | 10009-1 | Archimedes Planning Software is software installed on a laptop computer used for Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue. | LLZ | System, Image Processing, Radiological | 2 | Archimedes Access Key |
11 | 00856571007173 | 30005 | 30005 | LungPoint VBN Software is software installed on a desktop computer used to plan LungPoint VBN Software is software installed on a desktop computer used to plan procedures and navigate to targets in the lung. The LungPoint Procedure Program offers real-time navigation guidance for use during the bronchoscopy procedure. The software allows visualization of the bronchial tree; helps guide the tools in or adjacent to the bronchial tree; allows visualization of a predefined target in lung tissue; and assists with placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery. | LLZ | System, Image Processing, Radiological | 2 | LungPoint VBN System, V3.2 |
12 | 00856571007104 | 40009 | 40009 | Archimedes Planning Software is software installed on a laptop computer used for Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths on the computer or printed plan to the region of interest through both airways and lung tissue. | LLZ | System, Image Processing, Radiological | 2 | Archimedes Planning System |
13 | 00856571007234 | 12196-09 | 10009-09 | A collection of sterile devices designed to access and perform a biopsy sample d A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy. | EOQ | Bronchoscope (Flexible Or Rigid) | 2 | Archimedies Access Kit with Syringe |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00191506008024 | M00542820 | M00542820 | Monitor Mount | Exalt™ | BOSTON SCIENTIFIC CORPORATION |
2 | 00191506007997 | M0054279Z0 | M0054279Z0 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
3 | 00191506007980 | M0054279R0 | M0054279R0 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
4 | 00191506007966 | M0054279H0 | M0054279H0 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
5 | 00191506007959 | M00542790 | M00542790 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
6 | 00191506007942 | M0054278Z0 | M0054278Z0 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
7 | 00191506007935 | M0054278R0 | M0054278R0 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
8 | 00191506007911 | M0054278H0 | M0054278H0 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
9 | 00191506007904 | M00542780 | M00542780 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
10 | 00191506007898 | M0054277Z0 | M0054277Z0 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
11 | 00191506007881 | M0054277R0 | M0054277R0 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
12 | 00191506007867 | M0054277H0 | M0054277H0 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
13 | 00191506007850 | M00542770 | M00542770 | Monitor | Exalt ™ | BOSTON SCIENTIFIC CORPORATION |
14 | 00191506007843 | M0054276Z0 | M0054276Z0 | Monitor | EXALT™ | BOSTON SCIENTIFIC CORPORATION |
15 | 00191506007836 | M0054276R0 | M0054276R0 | Monitor | EXALT™ | BOSTON SCIENTIFIC CORPORATION |
16 | 00191506007812 | M0054276H0 | M0054276H0 | Monitor | EXALT™ | BOSTON SCIENTIFIC CORPORATION |
17 | 00191506007805 | M00542760 | M00542760 | Monitor | EXALT™ | BOSTON SCIENTIFIC CORPORATION |
18 | 00191506007485 | M00542750 | M00542750 | Single-Use Bronchoscope | EXALT™ Model B | BOSTON SCIENTIFIC CORPORATION |
19 | 00191506007454 | M00542730 | M00542730 | Single-Use Bronchoscope | EXALT™ Model B | BOSTON SCIENTIFIC CORPORATION |
20 | 00191506007423 | M00542710 | M00542710 | Single-Use Bronchoscope | EXALT™ Model B | BOSTON SCIENTIFIC CORPORATION |
21 | B634SW0121940202000 | Version 2.2.1 | Monarch Software Laptop v2.2.1 | Monarch Software Laptop v2.2.1 | AURIS HEALTH, INC. | |
22 | B634SW0121930202000 | Version 2.2.1 | Monarch Software Cart v2.2.1 | Monarch Software Cart v2.2.1 | AURIS HEALTH, INC. | |
23 | B634SW0121920202000 | Version 2.2.1 | Monarch Software Tower v2.2.1 | Monarch Software Tower v2.2.1 | AURIS HEALTH, INC. | |
24 | B634SW0121900201060 | Version 2.1.6 | Monarch Software Laptop v2.1.6 | Monarch Software Laptop v2.1.6 | AURIS HEALTH, INC. | |
25 | B634SW0121890201060 | Version 2.1.6 | Monarch Software Cart v2.1.6 | Monarch Software Cart v2.1.6 | AURIS HEALTH, INC. | |
26 | B634SW0121880201060 | Version 2.1.6 | Monarch Software Tower v2.1.6 | Monarch Software Tower v2.1.6 | AURIS HEALTH, INC. | |
27 | B634SW0032760201050 | Version 2.1.5 | Monarch™ Software Laptop v2.1.5 | Monarch™ Software Laptop v2.1.5 | AURIS HEALTH, INC. | |
28 | B634SW0032760201040 | Version 2.1.4 | Monarch™ Software Laptop v2.1.4 | Monarch™ Software Laptop v2.1.4 | AURIS HEALTH, INC. | |
29 | B634SW0032760201030 | Version 2.1.3 | Monarch™ Software Laptop v2.1.3 | Monarch™ Software Laptop v2.1.3 | AURIS HEALTH, INC. | |
30 | B634SW0032760201020 | Version 2.1.2 | Monarch™ Software Laptop v2.1.2 | Monarch™ Software Laptop v2.1.2 | AURIS HEALTH, INC. | |
31 | B634SW0032750201050 | Version 2.1.5 | Monarch™ Software Cart v2.1.5 | Monarch™ Software Cart v2.1.5 | AURIS HEALTH, INC. | |
32 | B634SW0032750201040 | Version 2.1.4 | Monarch™ Software Cart v2.1.4 | Monarch™ Software Cart v2.1.4 | AURIS HEALTH, INC. | |
33 | B634SW0032750201030 | Version 2.1.3 | Monarch™ Software Cart v2.1.3 | Monarch™ Software Cart v2.1.3 | AURIS HEALTH, INC. | |
34 | B634SW0032750201020 | Version 2.1.2 | Monarch™ Software Cart v2.1.2 | Monarch™ Software Cart v2.1.2 | AURIS HEALTH, INC. | |
35 | B634SW0032740201050 | Version 2.1.5 | Monarch™ Software Tower v2.1.5 | Monarch™ Software Tower v2.1.5 | AURIS HEALTH, INC. | |
36 | B634SW0032740201040 | Version 2.1.4 | Monarch™ Software Tower v2.1.4 | Monarch™ Software Tower v2.1.4 | AURIS HEALTH, INC. | |
37 | B634SW0032740201030 | Version 2.1.3 | Monarch™ Software Tower v2.1.3 | Monarch™ Software Tower v2.1.3 | AURIS HEALTH, INC. | |
38 | B634SW0032740201020 | Version 2.1.2 | Monarch™ Software Tower v2.1.2 | Monarch™ Software Tower v2.1.2 | AURIS HEALTH, INC. | |
39 | B634MON0007090 | MON-000709 | MON-000709 | Window Field Generator, Connection Cable, Mounting System | Monarch Advanced Imaging Accessory Kit | AURIS HEALTH, INC. |
40 | B634MON0000060 | MON-000006 | The Monarch Bronchoscope enables electro-mechanical articulation and precise con The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.Monarch Bronchscope 2.0/Monarch Platform (P2) | Monarch Bronchscope 2.0/Monarch Platform (P2) | AURIS HEALTH, INC. | |
41 | B634MON000005R0 | MON000005R | MON000005R | The Monarch Platform (Refurbished) enables electro-mechanical articulation and p The Monarch Platform (Refurbished) enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator. | Monarch™ Platform (Refurbished) | AURIS HEALTH, INC. |
42 | B634MON00000501R0 | MON-000005-01R | Monarch Endoscopy Platform (P1) System, Refurbished | Monarch Endoscopy Platform (P1) System, Refurbished | AURIS HEALTH, INC. | |
43 | B634MON000005010 | MON-000005-01 | Monarch Endoscopy Platform (P1) Tower Upgrade | Monarch Endoscopy Platform (P1) Tower Upgrade | AURIS HEALTH, INC. | |
44 | B634MON00000501 | MON-000005-01 | Monarch Endoscopy Platform (P1) Tower Upgrade | Monarch Endoscopy Platform (P1) Tower Upgrade | AURIS HEALTH, INC. | |
45 | B634MON0000050 | MON000005 | MON000005 | The Monarch Platform enables electro-mechanical articulation and precise control The Monarch Platform enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator. | Monarch™ Platform | AURIS HEALTH, INC. |
46 | B634MBR0002180 | MBR-000218 | MBR-000218 | Bronchoscope Fluidics Tubing | Bronchoscope Fluidics Tubing | AURIS HEALTH, INC. |
47 | B634MBR000211A0 | MBR-000211-A | MRB-000211-A | Monarch Bronchoscope | AURIS HEALTH, INC. | |
48 | B634MBR0000200 | MBR-000020 | MBR-000020 | Bronchoscope Sheath Valve | Bronchoscope Sheath Valve | AURIS HEALTH, INC. |
49 | B634MBR0000190 | MBR-000019 | MBR-000019 | Bronchoscope Valve | Bronchoscope Valve | AURIS HEALTH, INC. |
50 | B634MBR0000180 | MBR-000018 | MBR-000018 | Bronchoscope Fluidics Tubing | Bronchoscope Fluidics Tubing | AURIS HEALTH, INC. |