| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 17311091118124 | 111812 | 111812 | HemoCue Hb 301 Microcuvettes 4x50 vial | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Hb 301 Microcuvettes |
| 2 | 17311091118094 | 111809 | 111809 | HemoCue Hb 301 Microcuvettes 4x50 vial | GKR | System, Hemoglobin, Automated | HemoCue® Hb 301 Microcuvettes | |
| 3 | 17311091118070 | 111807 | 111807 | HemoCue Hb 301 Microcuvettes 4x75 vial | GKR | System, Hemoglobin, Automated | HemoCue® Hb 301 Microcuvettes | |
| 4 | 17311091118018 | 111801 | 111801 | HemoCue Hb 301 Microcuvettes 4x50 vial | GKR | System, Hemoglobin, Automated | HemoCue® Hb 301 Microcuvettes | |
| 5 | 07311091214447 | 121444 | 121444 | HemoCue Glucose 201 DM Analyzer mmol/L plasma | LFR | Glucose Dehydrogenase, Glucose | 2 | HemoCue® Glucose 201 DM Analyzer |
| 6 | 07311091214225 | 121422 | 121422 | HemoCue Glucose 201 DM Analyzer mg/dL plasma | LFR | Glucose Dehydrogenase, Glucose | 2 | HemoCue® Glucose 201 DM Analyzer |
| 7 | 07311091219206 | 121920 | 121920 | HemoCue Hb 801 Analyzer g/dL | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Hb 801 Analyzer |
| 8 | 07311091211460 | 121146 | 121146 | HemoCue Hb 201 DM Analyzer g/L | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Hb 201 DM Analyzer |
| 9 | 07311091211354 | 121135 | 121135 | HemoCue Hb 201 DM Analyzer g/dL | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Hb 201 DM Analyzer |
| 10 | 17311091218046 | 121804 | 121804 | HemoCue Hb301 Analyzer g/dL | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Hb301 Analyzer |
| 11 | 17311091107234 | 110723 | 110723 | HemoCue Glucose 201 Microcuvettes 2x25 single | CGA | Glucose Oxidase, Glucose | 2 | HemoCue® Glucose 201 Microcuvettes |
| 12 | 17311091107067 | 110706 | 110706 | HemoCue Glucose 201 Microcuvettes 4x25 vial | CGA | Glucose Oxidase, Glucose | HemoCue® Glucose 201 Microcuvettes | |
| 13 | 17311091107050 | 110705 | 110705 | HemoCue Glucose 201 Microcuvettes 4x25 single | CGA | Glucose Oxidase, Glucose | 2 | HemoCue® Glucose 201 Microcuvettes |
| 14 | 07311091218278 | 121827 | 121827 | HemoCue Hb301 Analyzer g/dL | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Hb301 Analyzer |
| 15 | 07311091203144 | 120314 | 120314 | HemoCue Plasma/Low Hb Photometer mg/dL | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Plasma/Low Hb Photometer |
| 16 | 17311091117325 | 111732 | 111732 | HemoCue Hb 201 Microcuvettes 4x25 single | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Hb 201 Microcuvettes |
| 17 | 17311091117318 | 111731 | 111731 | HemoCue Hb 201 Microcuvettes 4x50 vial | GKR | System, Hemoglobin, Automated | HemoCue® Hb 201 Microcuvettes | |
| 18 | 17311091117165 | 111716 | 111716 | HemoCue Hb 201 Microcuvettes 4x50 vial | GKR | System, Hemoglobin, Automated | HemoCue® Hb 201 Microcuvettes | |
| 19 | 17311091117158 | 111715 | 111715 | HemoCue Hb 201 Microcuvettes 4x25 single | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Hb 201 Microcuvettes |
| 20 | 07311091230010 | 123001 | 123001 | HemoCue WBC Analyzer x10^9 /L | GKL | Counter, Cell, Automated (Particle Counter) | 2 | HemoCue® WBC Analyzer |
| 21 | 17311091130034 | 113003 | 113003 | HemoCue WBC Microcuvettes 4x40 vial | GKL | Counter, Cell, Automated (Particle Counter) | HemoCue® WBC Microcuvettes | |
| 22 | 17311091103021 | 110302 | 110302 | HemoCue Plasma/Low Hb Microcuvettes 4x25 vial | GKR | System, Hemoglobin, Automated | HemoCue® Plasma/Low Hb Microcuvettes | |
| 23 | 07311091217219 | 121721 | 121721 | HemoCue Hb 201+ Analyzer g/dL | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Hb 201+ Analyzer |
| 24 | 07311091217202 | 121720 | 121720 | HemoCue Hb 201+ Analyzer g/L | GKR | System, Hemoglobin, Automated | 2 | HemoCue® Hb 201+ Analyzer |
| 25 | 07311091207074 | 120707 | 120707 | HemoCue Glucose 201 Analyzer mmol/L whole blood | CGA | Glucose Oxidase, Glucose | 2 | HemoCue® Glucose 201 Analyzer |
| 26 | 07311091207067 | 120706 | 120706 | HemoCue Glucose 201 Analyzer mg/dL plasma | CGA | Glucose Oxidase, Glucose | 2 | HemoCue® Glucose 201 Analyzer |
| 27 | 17311091119022 | 111902 | 111902 | HemoCue Hb 801 Microcuvettes 4x50 vial | GKR | System, Hemoglobin, Automated | HemoCue® Hb 801 Microcuvettes | |
| 28 | 17311091106084 | 110608 | 110608 | HemoCue Urine Albumin Microcuvettes 2x25 single | KQO | Automated Urinalysis System | HemoCue® Urine Albumin Microcuvettes | |
| 29 | 07311091206237 | 120623 | 120623 | HemoCue Albumin 201 Analyzer mg/L | KQO | Automated Urinalysis System | 1 | HemoCue® Albumin 201 Analyzer |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 04048534002011 | 0760-0101 | 0760-0101 | EKF Link is a data and device management system that enables healthcare professi EKF Link is a data and device management system that enables healthcare professionals to transfer, manage, store and display measurement results from point -of-care diagnostic testing analyzers. EKF Link enables the allocation of additional information to measurement results and facilitates the export or transfer of data for documentation purposes.EKF Link is intended to be used as an optional software application with EKF point -of-care analyzers and open to be interfaced to other vendor’s point-of-care testing analyzers verified for connection with EKF Link.EKF Link facilitates the setting of configurable options of connected analyzers. | EKF Link | EKF-DIAGNOSTIC GMBH |
| 2 | 04015630942305 | 06884750001 | 06884750001 | B-Gate Interface | ROCHE DIAGNOSTICS GMBH | |
| 3 | 04015630936007 | 07154003001 | 07154003001 | cobas® infinity central lab | ROCHE DIAGNOSTICS GMBH | |
| 4 | 04015630929078 | 05349966001 | 05349966001 | cobas p 701 Post-Analytical Unit | ROCHE DIAGNOSTICS GMBH | |
| 5 | 04015630929061 | 05158494001 | 05158494001 | cobas p 501 post-analytical unit | ROCHE DIAGNOSTICS GMBH | |
| 6 | 04015630035342 | 04420306001 | 04420306001 | cobas IT 1000 | ROCHE DIAGNOSTICS GMBH | |
| 7 | 03770027519041 | TD-Web | TD-Web is a web solution to easily manage orders creation, optimize collection TD-Web is a web solution to easily manage orders creation, optimize collection management and provide real-time results access at the patient’s bedside. | TD-Web | TECHNIDATA | |
| 8 | 03770027519034 | TDWorkstation | TDWorkstation is a powerful software designed to interface instruments with any TDWorkstation is a powerful software designed to interface instruments with any Laboratory Information System (LIS) and manage results with efficiency and flexibility. | TDWorkstation | TECHNIDATA | |
| 9 | 03770027519010 | TDHisto/Cyto | TDHisto/Cyto is a software used for managing medical information in the field TDHisto/Cyto is a software used for managing medical information in the field of laboratories performing histology, non-gynecological and gynecological cytology and autopsy activities.. | TDHisto/Cyto | TECHNIDATA | |
| 10 | 03770027519003 | TDNexLabs | TDNexLabs is a Laboratory Information System (LIS) (software product) intended t TDNexLabs is a Laboratory Information System (LIS) (software product) intended to be used for the management of clinical information.TDNexLabs is intended to be used only by health professionals. | TDNexLabs | TECHNIDATA | |
| 11 | 00883489001450 | GP200 | Rightest | BIONIME CORPORATION | ||
| 12 | 00883489000873 | GP200 | GE | BIONIME CORPORATION | ||
| 13 | 00862696000289 | 0 | a calculator/data processing module for clinical use described as electronic dev a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process laboratory data. | BG Analytics Software | ASSOCIATES OF CAPE COD, INC. | |
| 14 | 00859519002247 | DMS | The Telserve® Data Management System is an accessory to blood glucose monitoring The Telserve® Data Management System is an accessory to blood glucose monitoring systems for the review and evaluation of blood glucose test results to aid in diabetes management. | Telserve® Data Management System | TELCARE, LLC | |
| 15 | 00859474006397 | 1.0.6.2 | SoftTotalQC | SCC SOFT COMPUTER | ||
| 16 | 00859474006861 | 3.5.52.0 | SoftMolecular | SCC SOFT COMPUTER | ||
| 17 | 00859474006854 | 3.5.52.0 | SoftHLA | SCC SOFT COMPUTER | ||
| 18 | 00859474006847 | 3.5.52.0 | SoftFlowCytometry | SCC SOFT COMPUTER | ||
| 19 | 00859474006830 | 3.5.52.0 | SoftPathDx | SCC SOFT COMPUTER | ||
| 20 | 00859474006823 | 3.5.52.0 | SoftCytogenetics | SCC SOFT COMPUTER | ||
| 21 | 00859474006816 | 3.5.52.0 | SoftBiochemistry | SCC SOFT COMPUTER | ||
| 22 | 00859474006632 | 4.5.5.51 | SoftLab | SCC SOFT COMPUTER | ||
| 23 | 00859474006625 | 4.5.5.51 | SoftMic | SCC SOFT COMPUTER | ||
| 24 | 00859474006618 | 4.5.5.51 | SoftROE | SCC SOFT COMPUTER | ||
| 25 | 00859474006595 | 4.5.7.3 | SoftMic | SCC SOFT COMPUTER | ||
| 26 | 00859474006588 | 4.5.7.3 | SoftLab | SCC SOFT COMPUTER | ||
| 27 | 00859474006571 | 4.5.7.3 | SoftROE | SCC SOFT COMPUTER | ||
| 28 | 00859474006564 | 4.5.8.0 | SoftROE | SCC SOFT COMPUTER | ||
| 29 | 00859474006557 | 4.0.8.4 | SoftROE | SCC SOFT COMPUTER | ||
| 30 | 00859474006540 | 2.0.4.0 | SoftWebPlus | SCC SOFT COMPUTER | ||
| 31 | 00859474006533 | 1.1.1.4 | SoftWebPlus | SCC SOFT COMPUTER | ||
| 32 | 00859474006519 | 4.5.8.0 | SoftMic | SCC SOFT COMPUTER | ||
| 33 | 00859474006502 | 4.5.8.0 | SoftLab | SCC SOFT COMPUTER | ||
| 34 | 00859474006496 | 4.0.8.4 | SoftMic | SCC SOFT COMPUTER | ||
| 35 | 00859474006489 | 4.0.8.4 | SoftLab | SCC SOFT COMPUTER | ||
| 36 | 00859474006441 | 1.1.3.1 | SoftWebPlus | SCC SOFT COMPUTER | ||
| 37 | 00859474006434 | 1.0.7.0 | SoftTotalQC | SCC SOFT COMPUTER | ||
| 38 | 00859474006427 | 2.6.0.11 | SoftID | SCC SOFT COMPUTER | ||
| 39 | 00859474006359 | 1.0.6.1 | SoftTotalQC | SCC SOFT COMPUTER | ||
| 40 | 00859474006335 | 2.6.0.10 | SoftID | SCC SOFT COMPUTER | ||
| 41 | 00859474006274 | 2.6.0.9 | SoftID | SCC SOFT COMPUTER | ||
| 42 | 00859474006267 | 1.0.6.0 | SoftTotalQC | SCC SOFT COMPUTER | ||
| 43 | 00859474006199 | 2.6.0.8 | SoftID | SCC SOFT COMPUTER | ||
| 44 | 00859474006076 | 2.6.0.7 | SoftID | SCC SOFT COMPUTER | ||
| 45 | 00854067005238 | EHS-SDMK-V | Smart Diabetes Voice Glucose Monitor | Smart Diabetes | VALUE PROVIDERS LLC | |
| 46 | 00853023006159 | 27.2.2 | Laboratory Information System application software | NOVIUS Lab | CERNER CORPORATION | |
| 47 | 00850040853001 | Maestro RPM | Health Harmony Maestro is a component of the Health Harmony Remote Patient Monit Health Harmony Maestro is a component of the Health Harmony Remote Patient Monitoring system. It is a web-based software application that is used by healthcare providers for clinical data management and communication with patients. The Health Harmony Maestro dashboard provides a snapshot of patient data including vital signs and answers to symptom and behavior questions. Patient responses and medical device readings are risk stratified based on customer and/or individual thresholds set by the clinician. Alerts display on the dashboard triage page by the most recent date. At a glance, the clinician is able to detect patient data that is outside of threshold settings. Beyond the dashboard, detailed information may be viewed at a patient level as indicated. Clinicians can send messages to the patient that will be displayed on the Health Harmony Mobile application. Video conferencing between the clinician and patient is also available within the Health Harmony applications. | Health Harmony | CARE INNOVATIONS, LLC | |
| 48 | 00810055816101 | 3.5.68.1 | SoftTrack | SCC SOFT COMPUTER | ||
| 49 | 00810055816095 | 3.5.68.1 | SoftMic | SCC SOFT COMPUTER | ||
| 50 | 00810055816088 | 3.5.68.1 | SoftMolecular | SCC SOFT COMPUTER |