| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00763000500993 | BB11N31R1 | CUSTOM PACK BB11N31R1 RESEARCH PACK | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
| 2 | 00763000500979 | BB11N23R | CUSTOM PACK BB11N23R 10PK XTRASUC | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
| 3 | 00763000500962 | BB10R11R5 | CUSTOM PACK BB10R11R5 PUMP PK | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
| 4 | 00763000500948 | BB5Z34R5 | CUSTOM PACK BB5Z34R5 NURSES | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
| 5 | 00763000500931 | BB11G46R1 | CUSTOM PACK BB11G46R1 RQST2 | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
| 6 | 00763000500634 | 7H97R2 | CUSTOM PACK 7H97R2 25PK FEMALE ADAPT | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
| 7 | 00763000500559 | HY10Z01R8 | CUSTOM PACK HY10Z01R8 SUPPORT PACK | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
| 8 | 00763000501105 | BB5B82R2 | CUSTOM PACK BB5B82R2 5PK SUPPLE 2 | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
| 9 | 00763000511555 | ONYXNG35012UX | STENT ONYXNG35012UX ONYX 3.50X12RX | NIQ | Coronary drug-eluting stent | 3 | Onyx Frontier™ | |
| 10 | 00763000498535 | BB11L44R2 | CUSTOM PACK BB11L44R2 OPEN HEART | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
| 11 | 00763000511470 | ONYXNG30015UX | STENT ONYXNG30015UX ONYX 3.00X15RX | NIQ | Coronary drug-eluting stent | 3 | Onyx Frontier™ | |
| 12 | 00763000511418 | ONYXNG27526UX | STENT ONYXNG27526UX ONYX 2.75X26RX | NIQ | Coronary drug-eluting stent | 3 | Onyx Frontier™ | |
| 13 | 00763000511326 | ONYXNG25026UX | STENT ONYXNG25026UX ONYX 2.50X26RX | NIQ | Coronary drug-eluting stent | 3 | Onyx Frontier™ | |
| 14 | 00763000489472 | HY7Y30R18 | CUSTOM PACK HY7Y30R18 EC AMBU | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
| 15 | 00763000489434 | BB7L75R3 | CUSTOM PACK BB7L75R3 10PK 3/8X 72 | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
| 16 | 00763000426422 | B3301533M | LEAD B3301533M SENSIGHT 1.5MM EMAN LJ53 | MHY,MRU,NHL,PJS,MBX | Stimulator, electrical, implanted, for parkinsonian tremor,implanted subcortical Stimulator, electrical, implanted, for parkinsonian tremor,implanted subcortical electrical Stimulator (motor disorders),Stimulator, electrical, implanted, for parkinsonian symptoms,Stimulator, electrical, implanted, for essential tremor,Stimulator, thalamic, epilepsy, implanted | 3 | SenSight™ | |
| 17 | 00763000426408 | B3300542M | LEAD B3300542M SENSIGHT 0.5MM EMAN LJ53 | MBX,NHL,MRU,PJS,MHY | Stimulator, thalamic, epilepsy, implanted,Stimulator, electrical, implanted, for Stimulator, thalamic, epilepsy, implanted,Stimulator, electrical, implanted, for parkinsonian symptoms,implanted subcortical electrical Stimulator (motor disorders),Stimulator, electrical, implanted, for essential tremor,Stimulator, electrical, implanted, for parkinsonian tremor | 3 | SenSight™ | |
| 18 | 00763000334178 | 11D35R | CUSTOM PACK 11D35R RETO5 | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
| 19 | 00763000334130 | 11D33R | CUSTOM PACK 11D33R RETO1 | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
| 20 | 00763000306144 | ETBF3216C166E | STENT GRAFT ETBF3216C166E ENDUR II BIF | MIH | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 3 | Endurant® II | |
| 21 | 00763000305659 | ETLW1624C93E | STENT GRAFT ETLW1624C93E ENDUR II LIMB | MIH | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 3 | Endurant® II | |
| 22 | 00763000305598 | ETLW1620C82E | STENT GRAFT ETLW1620C82E ENDUR II LIMB | MIH | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 3 | Endurant® II | |
| 23 | 00763000271220 | 7800RR36 | RING 7800RR36 SIMUFORM SR 36MM US | KRH | RING, ANNULOPLASTY | 2 | SimuForm™ | |
| 24 | 00763000271107 | 7700FR32 | RING 7700FR32 SIMUPLUS FLEX 32MM US | KRH | RING, ANNULOPLASTY | 2 | SimuPlus™ | |
| 25 | 00763000499945 | BB5U74R18 | CUSTOM PACK BB5U74R18 TUBING | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
| 26 | 00763000499921 | BB8S37R29 | CUSTOM PACK BB8S37R29 PUMP TBL | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
| 27 | 00763000511647 | ONYXNG40012UX | STENT ONYXNG40012UX ONYX 4.00X12RX | NIQ | Coronary drug-eluting stent | 3 | Onyx Frontier™ | |
| 28 | 00763000498870 | CB11N89R | CUSTOM PACK CB11N89R MAN/BRIDGE | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
| 29 | 00763000260743 | VNMC2828C90TU | STENT GRAFT VNMC2828C90TU VAL NAV CS | MIH | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 3 | Valiant Navion™ | |
| 30 | 00763000001377 | BB8B73R7 | CUSTOM PACK BB8B73R7 PK | DWE | TUBING, PUMP, CARDIOPULMONARY BYPASS | 2 | NA | |
| 31 | 00681490024273 | 05328 | CABLE 05328 ATAKR EGM SAFETY 8FT | LPB | Cardiac ablation percutaneous catheter | 3 | NA | |
| 32 | 00673978549071 | 5344 | PLUG 5344 1/4 INCH | DWE | TUBING, PUMP, CARDIOPULMONARY BYPASS | 2 | NA | |
| 33 | 00643169796454 | AB9U20100090 | STENT AB9U20100090 ABRE V01 | QAN | Stent, iliac vein | 3 | Abre™ | |
| 34 | 00643169518919 | 97740 | PROG 97740 PATIENT MRICS SCS USA ROHS | LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3 | NA | |
| 35 | 00643169078024 | 500FA27 | MHV 500FA27 STD AORTIC | LWQ | HEART-VALVE, MECHANICAL | 3 | Open Pivot™ | |
| 36 | 00613994759221 | 680R32 | RING 680R32 PROFILE 3D 26L MEXICO | KRH | RING, ANNULOPLASTY | 2 | PROFILE 3D® | |
| 37 | 00613994691392 | 37642 | PRGMR 37642 PATIENT DBS W SC,PC,RC | MFR,NHL,MHY,OLM,MRU | Stimulator, brain, implanted, for behavior modification,STIMULATOR, ELECTRICAL, Stimulator, brain, implanted, for behavior modification,STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS,STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR,Deep brain stimulator for obsessive compulsive disorder (OCD),implanted subcortical electrical Stimulator (motor disorders) | 3 | NA | |
| 38 | 00613994334565 | 68005YN | CABLE 68005YN EGM 18L | OCL | Surgical Device, For cutting, coagulation, and/or ablation of tissue, including Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue | 2 | NA | |
| 39 | 00885074469669 | 365538 | TUNNEL TOOL 365538 ACCESSORY KIT US MKT | HAO | INSTRUMENT, SURGICAL, NON-POWERED | 1 | NA | |
| 40 | 00885074375458 | SB7MAC30 | CATHETER SB7MAC30 SB 7F 100CM MA30 | DQY | CATHETER, PERCUTANEOUS | 2 | SHERPA NX BALANCED | |
| 41 | 00885074372181 | SB7EBU40D | CATHETER SB7EBU40D SB 7F 90CM EB40 | DQY | CATHETER, PERCUTANEOUS | 2 | SHERPA NX BALANCED | |
| 42 | 00763000665982 | BB11V67R3 | CUSTOM PACK BB11V67R3 UMC | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
| 43 | 00763000552985 | CB11J56R3 | CUSTOM PACK CB11J56R3 PEDI MAG | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
| 44 | 00763000541118 | 6A32R2 | CUSTOM PACK 6A32R2 1/4X1/4 | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | NA | |
| 45 | 00763000400866 | 3320L | LIT 3320L DYSTONIA EMANUALS EN | MRU | implanted subcortical electrical Stimulator (motor disorders) | N/A | ||
| 46 | 00763000502843 | FMET-IM-SYS-S | SYSTEM SERVICED FMET-IM-SYS-S | DPW | FLOWMETER, BLOOD, CARDIOVASCULAR | 2 | FlowMet™ | |
| 47 | 00763000390891 | LA6ERADRST | CATHETER LA6ERADRST LA 6F 100CM ERDRS | DQY | Catheter, percutaneous | 2 | Launcher | |
| 48 | 00763000310332 | 37601 | INS 37601 ACTIVA PC DBS EMANUAL EN | OLM,MRU,MHY,NHL,MBX,PJS | Deep brain stimulator for obsessive compulsive disorder (OCD),implanted subcorti Deep brain stimulator for obsessive compulsive disorder (OCD),implanted subcortical electrical Stimulator (motor disorders),STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR,Stimulator, electrical, implanted, for parkinsonian symptoms,STIMULATOR, THALAMIC, EPILEPSY, IMPLANTED,Stimulator, electrical, implanted, for essential tremor | 3 | Activa® PC | |
| 49 | 00763000306519 | 104FS | FOOTSWITCH 104FS CRYOCONSOLE MDR | LPB | Cardiac ablation percutaneous catheter | 3 | N/A | |
| 50 | 00763000301330 | HC150A | HANDCRANK HC150A PLX 31L | DWA | Control, pump speed, cardiopulmonary bypass | 2 | Affinity™ |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00850677007419 | 5.2.X | CS.5.2 | PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medic PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images, videos and HL7 messages. It also handles user accounts, security, client configuration, and the folow of data between modalities and destination DICOM systems. PACSgear Enterprise exclusively supports PACSgear client products such as EHR Gateway, Image Link, MDR Video Touch and Web Forms. PACSgear Enterprise Server is not labeled for diagnostic use. | PACSgear Enterprise Server | HYLAND LLC |
| 2 | 00850677007396 | 5.1.X | PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medic PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data includingpatient demographics, images, videos, and HL7 messages. It also handles user accounts, security, clientconfiguration, and the flow of data between modalities and destination DICOM systems. PACSgear | PACSgear Enterprise Server | HYLAND LLC | |
| 3 | 00850677007389 | 1.X | Image Link Plus supports imaging workflows that do not follow the radiology work Image Link Plus supports imaging workflows that do not follow the radiology workflow by providing a pseudo order message to the modality that contains patient and visit information from the Electronic Medical Record (EMR). | Image Link Plus | HYLAND LLC | |
| 4 | 00850677007310 | 2.X | EHR-Gateway Print | HYLAND LLC | ||
| 5 | 00850677007303 | 2.X | Encounter Manager | Image Link Encounter Workflow | HYLAND LLC | |
| 6 | 00850677007297 | 3.X | Image Link | HYLAND LLC | ||
| 7 | 00850677007273 | 4.X | Web Forms | ModLink Web Forms | HYLAND LLC | |
| 8 | 00850677007266 | 3.X | EHR-Gateway | HYLAND LLC | ||
| 9 | 00850677007259 | 5.X | Core Server | PACSgear Enterprise Server | HYLAND LLC | |
| 10 | 00850677007235 | 2.X | EHR Gateway | PACSgear EHR Gateway | HYLAND LLC | |
| 11 | 00850677007228 | 3.X | Web Forms, Mod Link Web Forms | PACSgear Web Forms | HYLAND LLC | |
| 12 | 00850677007211 | 3.X | Mod LInk | PACSgear Mod Link | HYLAND LLC | |
| 13 | 00850677007204 | 1.X | Image Link Encounter Workflow | PACSgear Image Link Encounter Workflow | HYLAND LLC | |
| 14 | 00850677007198 | 2.X | Image Link | PACSgear Image Link | HYLAND LLC | |
| 15 | 00850677007167 | 4.X | PACSgear Core Server | PACSgear Core Server | HYLAND LLC | |
| 16 | 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 | |
| 17 | 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 | |
| 18 | 00850031821026 | Nile for HCPs | A digital epilepsy care management web portal for HCP. | Nile HCP | AI NILE INC | |
| 19 | 00850031821019 | Nile for Android | A digital epilepsy care management platform application for Android. | Nile | AI NILE INC | |
| 20 | 00850031821002 | Nile for iOS | A digital epilepsy care management platform application for iOS. | Nile | AI NILE INC | |
| 21 | 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 | |
| 22 | 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. | |
| 23 | 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 |
| 24 | 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 |
| 25 | 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 |
| 26 | 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 |
| 27 | 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 |
| 28 | 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 |
| 29 | 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 |
| 30 | 00841492104698 | 354018 | Responder | RAULAND-BORG CORPORATION | ||
| 31 | 00841492104681 | 354017 | Responder | RAULAND-BORG CORPORATION | ||
| 32 | 00841492104667 | 354016 | Responder | RAULAND-BORG CORPORATION | ||
| 33 | 00841492104643 | 354015 | Responder | RAULAND-BORG CORPORATION | ||
| 34 | 00841492104612 | 354012 | Responder | RAULAND-BORG CORPORATION | ||
| 35 | 00841492104582 | 354011 | Responder | RAULAND-BORG CORPORATION | ||
| 36 | 00841492104575 | 354010 | Responder | RAULAND-BORG CORPORATION | ||
| 37 | 00841492104568 | 354002 | Responder | RAULAND-BORG CORPORATION | ||
| 38 | 00841492104513 | 354001WP | Responder | RAULAND-BORG CORPORATION | ||
| 39 | 00841492104490 | 354001 | Responder | RAULAND-BORG CORPORATION | ||
| 40 | 00841492104476 | 354000 | Responder | RAULAND-BORG CORPORATION | ||
| 41 | 00841492104452 | 353200 | Responder | RAULAND-BORG CORPORATION | ||
| 42 | 00841492104445 | 353101 | Responder | RAULAND-BORG CORPORATION | ||
| 43 | 00841492104438 | 353100 | Responder | RAULAND-BORG CORPORATION | ||
| 44 | 00841492104421 | 353010 | Responder | RAULAND-BORG CORPORATION | ||
| 45 | 00841492104384 | 353001 | Responder | RAULAND-BORG CORPORATION | ||
| 46 | 00841492104360 | 353000 | Responder | RAULAND-BORG CORPORATION | ||
| 47 | 00841492104353 | 352021 | Responder | RAULAND-BORG CORPORATION | ||
| 48 | 00841492104339 | 352010 | Responder | RAULAND-BORG CORPORATION | ||
| 49 | 00841492104322 | 352004 | Responder | RAULAND-BORG CORPORATION | ||
| 50 | 00841492104308 | 352000 | Responder | RAULAND-BORG CORPORATION |