| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 05060434420237 | SO2 Sensor | 3003-001-010 | SO2 SO2 Twin | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | System M ® |
| 2 | 05060434420183 | Gas Module | 3003-030-011 | Low Flow - (0.5 - 3.0 L/min) | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | System M ® |
| 3 | 05060434420206 | Exhaust Module | 303-031-005 | Exhaust Module for use with Gas Modules as part of Gas Management System | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | System M ® |
| 4 | 05060434420190 | Gas Module | 3003-030-010 | High Flow - (1.0 - 7.0 L/min) | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | System M ® |
| 5 | 05060434420176 | Gas Module | 3003-030-013 | Ultra Low Flow - (0.05 - 0.5 L/min) | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | System M ® |
| 6 | 05060434420169 | Gas Management System | 3003-030-HB9 | High Flow - (1.0 - 7.0 L/min) - High Flow Gas Module (3003-030-010) & Exhaust Mo High Flow - (1.0 - 7.0 L/min) - High Flow Gas Module (3003-030-010) & Exhaust Module (3003-031-005) | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | System M ® |
| 7 | 05060434420152 | Gas Management System | 3003-030-LB9 | Low Flow - (0.5 - 3.0 L/min) - Low Flow Gas Module (3003-030-011) & Exhaust Modu Low Flow - (0.5 - 3.0 L/min) - Low Flow Gas Module (3003-030-011) & Exhaust Module (3003-031-005) | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | System M ® |
| 8 | 05060434420145 | Gas Management System | 3003-030-UB9 | Ultra Low Flow - (0.05 - 0.5 L/min) - Ultra Low Flow Gas Module (3003-030-013) & Ultra Low Flow - (0.05 - 0.5 L/min) - Ultra Low Flow Gas Module (3003-030-013) & Exhaust Module (3003-031-005) | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | System M ® |
| 9 | 05060434420084 | Hct / SO2 Sensor | 3003-010-023 | Tube ID 3/16" x Wall 1/16" (OD 5/16") | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | System M ® |
| 10 | 05060434420077 | Hct / SO2 Sensor | 3003-010-022 | Tube ID 1/4" x Wall 1/16" (OD 3/8") | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | System M ® |
| 11 | 05060434420060 | Hct / SO2 Sensor | 3003-010-021 | Tube ID 1/4" x Wall 3/32" (OD 7/16") | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | System M ® |
| 12 | 05060434420053 | Hct / SO2 Sensor | 3003-010-020 | Tube ID 3/8" x Wall 3/32" (OD 9/16") | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | System M ® |
| 13 | 05060434420046 | M4 | 3005-001-122 | Extracorporeal Blood Parameter Monitor | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | System M ® |
| 14 | 05060434420022 | M2 | 3005-001-110 | Extracorporeal Blood Parameter Monitor | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | System M ® |
| 15 | 05060434420008 | Quantum Workstation (QWS) | 51-000001-00 | Quantum Workstation | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | Quantum ® |
| 16 | 05060434420954 | Quantum Pump Frame 4 - New York (QPF4) | 51-000059-00 | Quantum Pump Frame 4 - New York | DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | Quantum ® |
| 17 | 05060434420893 | Resevoir Level Sensor | 43-000889 | Reservoir Level Sensor | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | Quantum ® |
| 18 | 05060434420886 | Pressure Sensor Assembly | 43-000918 | Quantum Pressure Sensor Assembly - 4.0m | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | Quantum ® |
| 19 | 05060434420824 | Quantum Pump Frame 3 - Vienna (QPF3) | 51-000056-00 | Quantum Pump Frame 3 - Vienna | DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | Quantum ® |
| 20 | 05060434420817 | Quantum Diagnostic Exhaust (QDE) | 51-000051-00 | Quantum Diagnostic Exhaust for use with Quantum Dagnostic Modules | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | Quantum ® |
| 21 | 05060434420800 | Quantum Pump Control Module (QCM) | 51-000003-00 | Quantum Pump Control Module | DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | Quantum ® |
| 22 | 05060434420794 | Quantum Roller Pump - 4 inch (QRP4) | 51-000011-00 | Quantum Roller Pump - 4 inch | DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | Quantum ® |
| 23 | 05060434420787 | Quantum Roller Pump - 6 inch (QRP6) | 51-000013-00 | Quantum Roller Pump - 6 inch | DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | Quantum ® |
| 24 | 05060434420770 | Quantum Roller Pump - 8 inch (QRP8) | 51-000008-00 | Quantum Roller Pump - 8 inch | DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | Quantum ® |
| 25 | 05060434420763 | Quantum Power Supply (QPS) | 51-000021-00 | Quantum Power Supply | DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | Quantum ® |
| 26 | 05060434420756 | Quantum Pump Frame 2 - Cheltenham (QPF2) | 51-000025-00 | Quantum Pump Frame 2 - Cheltenham | DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | Quantum ® |
| 27 | 05060434420749 | Quantum Pump Frame 1 - Blackpool (QPF1) | 51-000024-00 | Quantum Pump Frame 1 - Blackpool | DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | Quantum ® |
| 28 | 05060434420718 | Quantum Workstation 12 inch (QWS12) | 51-000031-00 | Quantum Workstation 12" | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | Quantum ® |
| 29 | 05060434420701 | Quantum Diagnostic Module (QDM1) | 51-000023-00 | Quantum Diagnostic Module | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | Quantum ® |
| 30 | 05060434420695 | Quantum Diagnostic Module - No Gas (QDM2) | 51-000032-00 | Quantum Diagnostic Module - No Gas | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | Quantum ® |
| 31 | 05060434420688 | Quantum Ventilation Module (QVM) | 51-000045-00 | Quantum Ventilation Module | DTX | Gas Control Unit, Cardiopulmonary Bypass | 2 | Quantum ® |
| 32 | 05060434420039 | QDMU | 3008-001-010 | Quantum Data Management Unit | OUG | Medical Device Data System | 1 | Quantum ® |
| 33 | 05060434420138 | Flow & Emboli Sensor | H11XLD | Tube ID 1/2" x Wall 3/32" (OD 11/16") | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | Quantum ® System M ® |
| 34 | 05060434420121 | Flow & Emboli Sensor | H9XLM | Tube ID 3/8" x Wall 3/32" (OD 9/16") | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | Quantum ® System M ® |
| 35 | 05060434420114 | Flow & Emboli Sensor | H7XLH | Tube ID 1/4" x Wall 3/32" (OD 7/16") | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | Quantum ® System M ® |
| 36 | 05060434420107 | Flow & Emboli Sensor | H6XLE | Tube ID 1/4" x Wall 1/16" (OD 3/8") | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | Quantum ® System M ® |
| 37 | 05060434420091 | Flow & Emboli Sensor | H5XLA | Tube ID 3/16" x Wall 1/16" (OD 5/16") | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | Quantum ® System M ® |
| 38 | 05060434423757 | SM.03.DTX | 51-000089-00 | CoolFlow SM.03.DTX Heat Transfer Fluid 1.5L | DWC | Controller, Temperature, Cardiopulmonary Bypass | 2 | Quantum |
| 39 | 05060434423443 | QSOR | 51-000074-01 | Quantum Smart Occluder - Right Hand | DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | Quantum |
| 40 | 05060434423436 | QSOL | 51-000022-01 | Quantum Smart Occluder - Left hand | DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | Quantum |
| 41 | 05060434423306 | QPR6 | 51-000139-00 | Quantum Pressure Sensor Assembly - 2.0m | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | Quantum |
| 42 | 05060434423290 | QPR5 | 51-000138-00 | Quantum Pressure Sensor Assembly - 1.2m | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | Quantum |
| 43 | 05060434423283 | QPR4 | 51-000137-00 | Quantum Pressure Sensor Assembly - 0.75m | DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | Quantum |
| 44 | 05060434423276 | QF35 | 51-000136-00 | Quantum Flow Sensor - ID 1/2" x Wall 3/32" (OD 11/16") 1.2m | DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | Quantum |
| 45 | 05060434423269 | QF34 | 51-000135-00 | Quantum Flow Sensor - ID 3/8" x Wall 3/32" (OD 9/16") 1.2m (QF34) | DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | Quantum |
| 46 | 05060434423252 | QF33 | 51-000134-00 | Quantum Flow Sensor - ID 1/4" x Wall 3/32" (OD 7/16") 1.2m (QF33) | DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | Quantum |
| 47 | 05060434423245 | QF32 | 51-000133-00 | Quantum Flow Sensor - ID 1/4" x Wall 1/16" (OD 3/8") 1.2m (QF32) | DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | Quantum |
| 48 | 05060434423238 | QF31 | 51-000132-00 | Quantum Flow Sensor - ID 3/16" x Wall 1/16" (OD 5/16") 1.2m (QF31) | DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | Quantum |
| 49 | 05060434423221 | QF30 | 51-000131-00 | Quantum Flow Sensor - ID 1/2" x Wall 3/32" (OD 11/16") 0.75m (QF30) Right Angled | DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | Quantum |
| 50 | 05060434423214 | QF29 | 51-000130-00 | Quantum Flow Sensor - ID 3/8" x Wall 3/32" (OD 9/16") 0.75m (QF29) Right Angled | DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | Quantum |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00850040853025 | Mobile RPM - Enterprise | Health Harmony Mobile is a component of the Health Harmony Remote Patient Monito Health Harmony Mobile is a component of the Health Harmony Remote Patient Monitoring system. It is a software client application that runs on a personal mobile device, used by patients to easily communicate and exchange information with their healthcare provider. The Health Harmony Mobile application collects patient responses to health assessment questions and receives patient vital signs from Bluetooth-connected medical measuring devices. The Mobile application automatically and securely transmits patient information to the provider. The Health Harmony Mobile application can also display educational material and other messages received from the provider, such as reminders encouraging patients to complete a health session or to take medications as ordered. Patients can read messages and send replies to the clinician, and may also accept or a decline a video conference call initiated by their clinician, directly from the Health Harmony Mobile application. The Enterprise version of Health Harmony Mobile is pre-loaded by the manufacturer on a personal mobile device that is provided to the patient in a Health Harmony Kit. | Health Harmony | CARE INNOVATIONS, LLC | |
| 2 | 00850040853018 | Mobile RPM - BYOD | Health Harmony Mobile is a component of the Health Harmony Remote Patient Monito Health Harmony Mobile is a component of the Health Harmony Remote Patient Monitoring system. It is a software client application that runs on a personal mobile device, used by patients to easily communicate and exchange information with their healthcare provider. The Health Harmony Mobile application collects patient responses to health assessment questions and receives patient vital signs from Bluetooth-connected medical measuring devices. The Mobile application automatically and securely transmits patient information to the provider. The Health Harmony Mobile application can also display educational material and other messages received from the provider, such as reminders encouraging patients to complete a health session or to take medications as ordered. Patients can read messages and send replies to the clinician, and may also accept or a decline a video conference call initiated by their clinician, directly from the Health Harmony Mobile application. The BYOD version of Health Harmony Mobile is available for download by the patient onto their own personal mobile device. | Health Harmony | CARE INNOVATIONS, LLC | |
| 3 | 00850031821026 | Nile for HCPs | A digital epilepsy care management web portal for HCP. | Nile HCP | AI NILE INC | |
| 4 | 00850031821019 | Nile for Android | A digital epilepsy care management platform application for Android. | Nile | AI NILE INC | |
| 5 | 00850031821002 | Nile for iOS | A digital epilepsy care management platform application for iOS. | Nile | AI NILE INC | |
| 6 | 00850015699016 | 43-5570-006-14 | After the surgery is completed, the OR Barcode Scanner can be used to scan the b After the surgery is completed, the OR Barcode Scanner can be used to scan the barcodes on the labels of the CTE and other implanted TKA components. | OR Barcode Scanner | CANARY MEDICAL USA LLC | |
| 7 | 00850010298061 | com.ekodevices.android.intl | Eko mobile app for android international platforms for use with Eko medical devices. | Eko Mobile App Android International | EKO DEVICES, INC. | |
| 8 | 00841709118319 | M9D-042 / 9A682001 | M9D-042-DL | The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, cl The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Ritter | MIDMARK CORPORATION |
| 9 | 00841709118296 | M9-042 / 9A682001 | M9-042-DL | The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, cl The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Ritter | MIDMARK CORPORATION |
| 10 | 00841709118289 | M9-041 / 9A682001 | M9-041-DL | The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, cl The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Midmark | MIDMARK CORPORATION |
| 11 | 00841709118272 | M9-040 / 9A682001 | M9-040-DL | The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, cl The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Midmark | MIDMARK CORPORATION |
| 12 | 00841709118241 | M11-042 / 9A682001 | M11-042-DL | The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, c The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Ritter | MIDMARK CORPORATION |
| 13 | 00841709118234 | M11-041 / 9A682001 | M11-041-DL | The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, c The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Midmark | MIDMARK CORPORATION |
| 14 | 00841709118227 | M11-040 / 9A682001 | M11-040-DL | The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, c The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Midmark | MIDMARK CORPORATION |
| 15 | 00841492104698 | 354018 | Responder | RAULAND-BORG CORPORATION | ||
| 16 | 00841492104681 | 354017 | Responder | RAULAND-BORG CORPORATION | ||
| 17 | 00841492104667 | 354016 | Responder | RAULAND-BORG CORPORATION | ||
| 18 | 00841492104643 | 354015 | Responder | RAULAND-BORG CORPORATION | ||
| 19 | 00841492104612 | 354012 | Responder | RAULAND-BORG CORPORATION | ||
| 20 | 00841492104582 | 354011 | Responder | RAULAND-BORG CORPORATION | ||
| 21 | 00841492104575 | 354010 | Responder | RAULAND-BORG CORPORATION | ||
| 22 | 00841492104568 | 354002 | Responder | RAULAND-BORG CORPORATION | ||
| 23 | 00841492104513 | 354001WP | Responder | RAULAND-BORG CORPORATION | ||
| 24 | 00841492104490 | 354001 | Responder | RAULAND-BORG CORPORATION | ||
| 25 | 00841492104476 | 354000 | Responder | RAULAND-BORG CORPORATION | ||
| 26 | 00841492104452 | 353200 | Responder | RAULAND-BORG CORPORATION | ||
| 27 | 00841492104445 | 353101 | Responder | RAULAND-BORG CORPORATION | ||
| 28 | 00841492104438 | 353100 | Responder | RAULAND-BORG CORPORATION | ||
| 29 | 00841492104421 | 353010 | Responder | RAULAND-BORG CORPORATION | ||
| 30 | 00841492104384 | 353001 | Responder | RAULAND-BORG CORPORATION | ||
| 31 | 00841492104360 | 353000 | Responder | RAULAND-BORG CORPORATION | ||
| 32 | 00841492104353 | 352021 | Responder | RAULAND-BORG CORPORATION | ||
| 33 | 00841492104339 | 352010 | Responder | RAULAND-BORG CORPORATION | ||
| 34 | 00841492104322 | 352004 | Responder | RAULAND-BORG CORPORATION | ||
| 35 | 00841492104308 | 352000 | Responder | RAULAND-BORG CORPORATION | ||
| 36 | 00841492104285 | 351310 | Responder | RAULAND-BORG CORPORATION | ||
| 37 | 00841492104261 | 351300 | Responder | RAULAND-BORG CORPORATION | ||
| 38 | 00841492104254 | 351205 | Responder | RAULAND-BORG CORPORATION | ||
| 39 | 00841492104186 | 351004 | Responder | RAULAND-BORG CORPORATION | ||
| 40 | 00841492104179 | 351003 | Responder | RAULAND-BORG CORPORATION | ||
| 41 | 00841492104155 | 351001 | Responder | RAULAND-BORG CORPORATION | ||
| 42 | 00841492104148 | 351000 | Responder | RAULAND-BORG CORPORATION | ||
| 43 | 00841492104094 | 350300 | Responder | RAULAND-BORG CORPORATION | ||
| 44 | 00841492104087 | 350034 | Responder | RAULAND-BORG CORPORATION | ||
| 45 | 00841492103899 | 3225300 | Responder | RAULAND-BORG CORPORATION | ||
| 46 | 00841492103806 | 301103 | Responder | RAULAND-BORG CORPORATION | ||
| 47 | 00841492102564 | R5KURTA | Responder | RAULAND-BORG CORPORATION | ||
| 48 | 00841492102557 | R5KUPS1 | Responder | RAULAND-BORG CORPORATION | ||
| 49 | 00841492102533 | R5KUPB2 | Responder | RAULAND-BORG CORPORATION | ||
| 50 | 00841492102526 | R5KUCNL | Responder | RAULAND-BORG CORPORATION |