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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Myrian® is a medical software for processing, management, advanced visualization, and analysis of multimodality medical images. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including radiologists, surgeons, clinicians and technicians. This device is not indicated for mammography use.
INTRASENSE
MYRIAN 2.9
In Commercial Distribution

  • 03700719700471 ()


  • Radiological PACS software
The ALPCO Calprotectin Immunoturbidimetric Assay is an in-vitro diagnostic assay intended for the quantitative measurement of human fecal calprotectin in human stool. The ALPCO Calprotectin Immunoturbidimetric Assay is intended for in-vitro diagnostic use as an aid in diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC), and as an aid in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory findings.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
80-CALPHU-IT200
In Commercial Distribution

  • B24280CALPHUIT2000 ()
80-CALPHU-IT200

  • Calprotectin IVD, kit, nephelometry/turbidimetry
The ALPCO Calprotectin Immunoturbidimetric Assay is an in-vitro diagnostic assay intended for the quantitative measurement of human fecal calprotectin in human stool. The ALPCO Calprotectin Immunoturbidimetric Assay is intended for in-vitro diagnostic use as an aid in diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC), and as an aid in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory findings.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
80-CALPHU-IT100
Not in Commercial Distribution

  • B24280CALPHUIT100 ()
80-CALPHU-IT100

  • Calprotectin IVD, kit, nephelometry/turbidimetry
Surveyor Central Station with S4 Wifi telemetry monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and dual color LCD 24 in. monitors with high resolution; Custom number of hard wired patient monitoring slots and telemetry channels; Redundant server (RAID1+0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia, 12-lead ST se
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262377 ()
SCSYS-HAB-SDFAA

  • Centralized patient monitor
Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and dual color LCD 24 in. monitors with high resolution; 0 hard wired patient monitoring slots and 16 telemetry channels (dual display recommended); Local storage for up to 600 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262278 ()
SCSYS-IAB-GBFAX

  • Centralized patient monitor
Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and dual color LCD 24 in. monitors with high resolution; 0 hard wired patient monitoring slots and 32 telemetry channels (dual display required); Local storage for up to 600 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended ar
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262261 ()
SCSYS-IAB-RBFAX

  • Centralized patient monitor
Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and dual color LCD 24 in. monitors with high resolution; Custom number of hard wired patient monitoring slots and telemetry channels; Redundant server (RAID1+0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation,
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262247 ()
SCSYS-IAB-SDFCA

  • Centralized patient monitor
Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; German language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and dual color LCD 24 in. monitors with high resolution; Custom number of hard wired patient monitoring slots and telemetry channels; Redundant server (RAID1+0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation,
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262223 ()
SCSYS-IDB-SDFCA

  • Centralized patient monitor
Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and dual color LCD 24" monitors with high resolution; 8 hard wired patient monitoring slots and 0 telemetry channels (single display required); Redundant server (RAID1+0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12- lead ECG inter
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094351262 ()
SCSYS-IAB-ADFCA

  • Centralized patient monitor
Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and dual color LCD 24" monitors with high resolution; 8 hard wired patient monitoring slots and 8 telemetry channels (dual display recommended); Redundant server (RAID1+0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12- lead ECG inte
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094351255 ()
SCSYS-IAB-FDFCA

  • Centralized patient monitor
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