| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04961333224685 | KW3115S | FDS | Gastroscope and accessories, flexible/rigid | PENTAX | |||
| 2 | 04961333224562 | KW2411S | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | PENTAX | |||
| 3 | 14961333221650 | CS-C11A | PROfILE Single Use Endoscope Cleaning Brush Kits | EOB | Nasopharyngoscope (Flexible Or Rigid) | N/A | ||
| 4 | 04961333225569 | EB19-J10U | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | 2 | N/A | ||
| 5 | 04961333224449 | KW1815S | FDS | Gastroscope and accessories, flexible/rigid | PENTAX | |||
| 6 | 14961333221612 | CS4010A | PROfILE Single Use Endoscope Cleaning Brush Kits | EOB | Nasopharyngoscope (Flexible Or Rigid) | N/A | ||
| 7 | 14961333221438 | OF-B205 | PENTAX Medical single use suction control valve | EOB | Nasopharyngoscope (Flexible Or Rigid) | N/A | ||
| 8 | 04961333251773 | EG17-J10 | PENTAX Medical Video Upper GI Scope EG17-J10 | FDS | Gastroscope and accessories, flexible/rigid | 2 | N/A | |
| 9 | 04961333251506 | EB19-J10 | PENTAX Medical Video Bronchoscope EB19-J10 (Made in Malaysia) | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | 2 | N/A | |
| 10 | 04961333251810 | EB11-J10 | PENTAX Medical Video Bronchoscope EB11-J10 (Made in Malaysia) | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | 2 | N/A | |
| 11 | 04961333251803 | EB11-J10 | PENTAX Medical Video Bronchoscope EB11-J10 | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | 2 | N/A | |
| 12 | 04961333251346 | VNL15-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL15-J10 (Made in Malaysia, Ele PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL15-J10 (Made in Malaysia, Electronic IFU) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
| 13 | 04961333251322 | VNL15-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL15-J10 (Made in Malaysia) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
| 14 | 04961333251254 | VNL8-J10 | "PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL8-J10 (Made in Malaysia, Ele "PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL8-J10 (Made in Malaysia, Electronic IFU) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
| 15 | 04961333251230 | VNL8-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL8-J10 (Made in Malaysia) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
| 16 | 04961333251179 | VNL11-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL11-J10 (Made in Malaysia, Ele PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL11-J10 (Made in Malaysia, Electronic IFU) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
| 17 | 04961333251155 | VNL11-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL11-J10 (Made in Malaysia) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
| 18 | 04961333249015 | EG38-J10UT | PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT (Made in Malaysia) | ODG,ITX | Endoscopic Ultrasound System, Gastroenterology-Urology,Transducer, Ultrasonic, Diagnostic | 2 | N/A | |
| 19 | 04961333248933 | EG36-J10UR | PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR (Made in Malaysia) | ODG,ITX | Endoscopic Ultrasound System, Gastroenterology-Urology,Transducer, Ultrasonic, Diagnostic | 2 | N/A | |
| 20 | 04961333248858 | EG34-J10U | PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U (Made in Malaysia) | ODG,ITX | Endoscopic Ultrasound System, Gastroenterology-Urology,Transducer, Ultrasonic, Diagnostic | 2 | N/A | |
| 21 | 04961333248315 | EG29-i10 | Made in Malaysia | FDS | Gastroscope and accessories, flexible/rigid | 2 | N/A | |
| 22 | 04961333248209 | EC38-i10L | Made in Malaysia | FDF | Colonoscope and accessories, flexible/rigid | 2 | N/A | |
| 23 | 04961333248179 | EG-2990i | Made in Malaysia | FDS | Gastroscope and accessories, flexible/rigid | 2 | N/A | |
| 24 | 04961333248148 | EC-3890Li | Made in Malaysia | FDF | Colonoscope and accessories, flexible/rigid | 2 | N/A | |
| 25 | 04961333248070 | VNL15-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL15-J10 (Electronic IFU) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
| 26 | 04961333248063 | VNL8-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL8-J10 (Electronic IFU) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
| 27 | 04961333248056 | VNL11-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL11-J10 (Electronic IFU) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
| 28 | 04961333247455 | ED34-i10T2 | FDT | duodenoscope and accessories, flexible/rigid | 2 | N/A | ||
| 29 | 04961333246632 | ED32-i10 | PENTAX Medical Video Duodenoscope ED32-i10 | FDT | duodenoscope and accessories, flexible/rigid | 2 | N/A | |
| 30 | 04961333245895 | EC34-i10TL | FDF | Colonoscope and accessories, flexible/rigid | 2 | N/A | ||
| 31 | 04961333245888 | EG34-i10 | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | N/A | ||
| 32 | 04961333244744 | EPK-3000 | Made in Thailand | PEA | Endoscope, accessories, image post-processing for color enhancement | 2 | DEFINA | |
| 33 | 04961333239696 | EG34-J10U | PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U | ODG,ITX | Endoscopic Ultrasound System, Gastroenterology-Urology,Transducer, Ultrasonic, Diagnostic | 2 | N/A | |
| 34 | 04961333239597 | EG36-J10UR | PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR | ODG,ITX | Endoscopic Ultrasound System, Gastroenterology-Urology,Transducer, Ultrasonic, Diagnostic | 2 | N/A | |
| 35 | 04961333239498 | EG38-J10UT | PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT | ODG,ITX | Endoscopic Ultrasound System, Gastroenterology-Urology,Transducer, Ultrasonic, Diagnostic | 2 | N/A | |
| 36 | 04961333225507 | EB19-J10 | PENTAX Medical Video Bronchoscope EB19-J10 | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | 2 | N/A | |
| 37 | 04961333225453 | EB15-J10 | PENTAX Medical Video Bronchoscope EB15-J10 | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | 2 | N/A | |
| 38 | 04961333233618 | EPK-i7010 | PEA | Endoscope, accessories, image post-processing for color enhancement | OPTIVISTA | |||
| 39 | 04961333232918 | EPK-i5500c | PEA | Endoscope, accessories, image post-processing for color enhancement | 2 | IMAGINA | ||
| 40 | 04961333248711 | EC34-i10cL | Made in Malaysia | FDF | Colonoscope and accessories, flexible/rigid | 2 | IMAGINA | |
| 41 | 04961333248544 | EC38-i10cL | Made in Malaysia | FDF | Colonoscope and accessories, flexible/rigid | 2 | IMAGINA | |
| 42 | 04961333248483 | EG29-i10c | Made in Malaysia | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | IMAGINA | |
| 43 | 04961333247400 | EC38-i10cL | FDF | Colonoscope and accessories, flexible/rigid | 2 | IMAGINA | ||
| 44 | 04961333247394 | EC34-i10cL | FDF | Colonoscope and accessories, flexible/rigid | 2 | IMAGINA | ||
| 45 | 04961333247387 | EG29-i10c | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | IMAGINA | ||
| 46 | 04961333224821 | KA1811S | FBN | Choledochoscope and accessories, flexible/rigid | 2 | PENTAX | ||
| 47 | 04961333224807 | KH2430S | GCL | ESOPHAGOSCOPE, GENERAL & PLASTIC SURGERY | PENTAX | |||
| 48 | 04961333224784 | KH2422S | GCL | ESOPHAGOSCOPE, GENERAL & PLASTIC SURGERY | PENTAX | |||
| 49 | 04961333224746 | KH2415S | GCL | ESOPHAGOSCOPE, GENERAL & PLASTIC SURGERY | PENTAX | |||
| 50 | 04961333224722 | KH2411S | GCL | ESOPHAGOSCOPE, GENERAL & PLASTIC SURGERY | PENTAX |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | B634SW0121940202000 | Version 2.2.1 | Monarch Software Laptop v2.2.1 | Monarch Software Laptop v2.2.1 | AURIS HEALTH, INC. | |
| 2 | B634SW0121930202000 | Version 2.2.1 | Monarch Software Cart v2.2.1 | Monarch Software Cart v2.2.1 | AURIS HEALTH, INC. | |
| 3 | B634SW0121920202000 | Version 2.2.1 | Monarch Software Tower v2.2.1 | Monarch Software Tower v2.2.1 | AURIS HEALTH, INC. | |
| 4 | B634SW0121900201060 | Version 2.1.6 | Monarch Software Laptop v2.1.6 | Monarch Software Laptop v2.1.6 | AURIS HEALTH, INC. | |
| 5 | B634SW0121890201060 | Version 2.1.6 | Monarch Software Cart v2.1.6 | Monarch Software Cart v2.1.6 | AURIS HEALTH, INC. | |
| 6 | B634SW0121880201060 | Version 2.1.6 | Monarch Software Tower v2.1.6 | Monarch Software Tower v2.1.6 | AURIS HEALTH, INC. | |
| 7 | B634SW0032760201050 | Version 2.1.5 | Monarch™ Software Laptop v2.1.5 | Monarch™ Software Laptop v2.1.5 | AURIS HEALTH, INC. | |
| 8 | B634SW0032760201040 | Version 2.1.4 | Monarch™ Software Laptop v2.1.4 | Monarch™ Software Laptop v2.1.4 | AURIS HEALTH, INC. | |
| 9 | B634SW0032760201030 | Version 2.1.3 | Monarch™ Software Laptop v2.1.3 | Monarch™ Software Laptop v2.1.3 | AURIS HEALTH, INC. | |
| 10 | B634SW0032760201020 | Version 2.1.2 | Monarch™ Software Laptop v2.1.2 | Monarch™ Software Laptop v2.1.2 | AURIS HEALTH, INC. | |
| 11 | B634SW0032750201050 | Version 2.1.5 | Monarch™ Software Cart v2.1.5 | Monarch™ Software Cart v2.1.5 | AURIS HEALTH, INC. | |
| 12 | B634SW0032750201040 | Version 2.1.4 | Monarch™ Software Cart v2.1.4 | Monarch™ Software Cart v2.1.4 | AURIS HEALTH, INC. | |
| 13 | B634SW0032750201030 | Version 2.1.3 | Monarch™ Software Cart v2.1.3 | Monarch™ Software Cart v2.1.3 | AURIS HEALTH, INC. | |
| 14 | B634SW0032750201020 | Version 2.1.2 | Monarch™ Software Cart v2.1.2 | Monarch™ Software Cart v2.1.2 | AURIS HEALTH, INC. | |
| 15 | B634SW0032740201050 | Version 2.1.5 | Monarch™ Software Tower v2.1.5 | Monarch™ Software Tower v2.1.5 | AURIS HEALTH, INC. | |
| 16 | B634SW0032740201040 | Version 2.1.4 | Monarch™ Software Tower v2.1.4 | Monarch™ Software Tower v2.1.4 | AURIS HEALTH, INC. | |
| 17 | B634SW0032740201030 | Version 2.1.3 | Monarch™ Software Tower v2.1.3 | Monarch™ Software Tower v2.1.3 | AURIS HEALTH, INC. | |
| 18 | B634SW0032740201020 | Version 2.1.2 | Monarch™ Software Tower v2.1.2 | Monarch™ Software Tower v2.1.2 | AURIS HEALTH, INC. | |
| 19 | B634MON0007090 | MON-000709 | MON-000709 | Window Field Generator, Connection Cable, Mounting System | Monarch Advanced Imaging Accessory Kit | AURIS HEALTH, INC. |
| 20 | 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. | |
| 21 | 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. |
| 22 | B634MON00000501R0 | MON-000005-01R | Monarch Endoscopy Platform (P1) System, Refurbished | Monarch Endoscopy Platform (P1) System, Refurbished | AURIS HEALTH, INC. | |
| 23 | B634MON000005010 | MON-000005-01 | Monarch Endoscopy Platform (P1) Tower Upgrade | Monarch Endoscopy Platform (P1) Tower Upgrade | AURIS HEALTH, INC. | |
| 24 | B634MON00000501 | MON-000005-01 | Monarch Endoscopy Platform (P1) Tower Upgrade | Monarch Endoscopy Platform (P1) Tower Upgrade | AURIS HEALTH, INC. | |
| 25 | 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. |
| 26 | B634MBR0002180 | MBR-000218 | MBR-000218 | Bronchoscope Fluidics Tubing | Bronchoscope Fluidics Tubing | AURIS HEALTH, INC. |
| 27 | B634MBR000211A0 | MBR-000211-A | MRB-000211-A | Monarch Bronchoscope | AURIS HEALTH, INC. | |
| 28 | B634MBR0000200 | MBR-000020 | MBR-000020 | Bronchoscope Sheath Valve | Bronchoscope Sheath Valve | AURIS HEALTH, INC. |
| 29 | B634MBR0000190 | MBR-000019 | MBR-000019 | Bronchoscope Valve | Bronchoscope Valve | AURIS HEALTH, INC. |
| 30 | B634MBR0000180 | MBR-000018 | MBR-000018 | Bronchoscope Fluidics Tubing | Bronchoscope Fluidics Tubing | AURIS HEALTH, INC. |
| 31 | B634MBR0000170 | MBR-000017 | MBR-000017 | Bronchoscope Patient Introducer Kit | Bronchoscope Patient Introducer Kit | AURIS HEALTH, INC. |
| 32 | B634MBR0000160 | MBR-000016 | MBR-000016 | Navigation Patient Patches (Quantity of 60) | Navigation Patient Patches | AURIS HEALTH, INC. |
| 33 | B634MBR0000150 | MBR-000015 | MBR-000015 | Cytology Brush | Cytology Brush | AURIS HEALTH, INC. |
| 34 | B634MBR0000140 | MBR-000014 | MBR-000014 | Biopsy Forceps - Smooth Cup | Biopsy Forceps - Smooth Cup | AURIS HEALTH, INC. |
| 35 | B634MBR0000120 | MBR-000012 | MBR-000012 | Aspirating Biopsy Needle | Aspirating Biopsy Needle | AURIS HEALTH, INC. |
| 36 | B634MBR0000110 | MBR-000011 | MBR-000011 | Monarch™ Bronchoscope System | Monarch™ Bronchoscope System | AURIS HEALTH, INC. |
| 37 | B623MBR000211A0 | MBR-000211-A | MBR-000211-A | Monarch Bronchoscope | Monarch Bronchoscope | AURIS HEALTH, INC. |
| 38 | 44026704535604 | IPN008491 | 522581 | HOLINGER BRONCHOSCOPE 5X40 | PILLING | TELEFLEX INCORPORATED |
| 39 | 26948318968828 | M00515101 | Rescue™ Pulmonary Grasping Forceps | Rescue | ANREI MEDICAL(HZ) CO.,LTD. | |
| 40 | 24026704715569 | IPN008549 | 523160P | LASER BRONCHOSCOPE 9X40 | PILLING | TELEFLEX INCORPORATED |
| 41 | 24026704535662 | IPN008497 | 522587 | HOLINGER BRONCHOSCOPE 9X40 | PILLING | TELEFLEX INCORPORATED |
| 42 | 24026704535655 | IPN008496 | 522586 | HOLINGER BRONCHOSCOPE 8X40 | PILLING | TELEFLEX INCORPORATED |
| 43 | 24026704535648 | IPN008495 | 522585 | HOLINGER BRONCHOSCOPE 7X40 | PILLING | TELEFLEX INCORPORATED |
| 44 | 24026704535631 | IPN008494 | 522584 | HOLINGER BRONCHOSCOPE 6X40 | PILLING | TELEFLEX INCORPORATED |
| 45 | 24026704535624 | IPN008493 | 522583 | HOLINGER BRONCHOSCOPE 6X35 | PILLING | TELEFLEX INCORPORATED |
| 46 | 24026704535617 | IPN008492 | 522582 | HOLINGER BRONCHOSCOPE 5X45 | PILLING | TELEFLEX INCORPORATED |
| 47 | 24026704535594 | IPN008490 | 522580 | HOLINGER BRONCHOSCOPE 5X35 | PILLING | TELEFLEX INCORPORATED |
| 48 | 24026704535587 | IPN008489 | 522579 | HOLINGER BRONCHOSCOPE 5X30 | PILLING | TELEFLEX INCORPORATED |
| 49 | 24026704535570 | IPN008488 | 522578 | HOLINGER BRONCHOSCOPE 4X30 | PILLING | TELEFLEX INCORPORATED |
| 50 | 24026704535563 | IPN008487 | 522577 | HOLINGER BRONCHOSCOPE 3.5X30 | PILLING | TELEFLEX INCORPORATED |