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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KONSYL PHARMACEUTICALS, INC.
Round Hollow
In Commercial Distribution

  • 00610858081009 ()
  • 00610858081006 ()


  • Gastrointestinal telemetric monitoring system capsule, non-sterile
Stratus® CS STAT Fluorometric Analyzer Sarstedt cannula holds the stoppered tube in the sample manager.
Siemens Healthcare Diagnostics Inc.
10445064
In Commercial Distribution

  • 00842768004445 ()
  • 00630414009797 ()
CCANS

  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
For the cannulation of B-D Vacutainer® 4 or 5 mL lithium heparin collection tubes, with HEMOGARD® closure, to be used on the Stratus® CS STAT Fluorometric Analyzer.
Siemens Healthcare Diagnostics Inc.
10445063
In Commercial Distribution

  • 00842768004438 ()
  • 00630414009780 ()
CCANBD

  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
CELLTRACKS ANALYZER II - EU ROHS Compliant
MENARINI SILICON BIOSYSTEMS, INC.
9555
In Commercial Distribution

  • 10888385000658 ()
9555

  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
CellTracks Analyzer II - Refurbished
MENARINI SILICON BIOSYSTEMS, INC.
9555R
In Commercial Distribution

  • 10888385000627 ()
9555R

  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
Remote Review Work Station
MENARINI SILICON BIOSYSTEMS, INC.
9542
In Commercial Distribution

  • 10888385000085 ()
9542

  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
CellTracks Analyzer II
MENARINI SILICON BIOSYSTEMS, INC.
9555
In Commercial Distribution

  • 10888385000054 ()
9555

  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
The Stratus® CS STAT Fluorometric Analyzer is a microprocessor controlled instrument that measures analytes in body fluids for in vitro diagnostic use. The instrument is intended for use by trained healthcare professionals in the clinical laboratory and point of care settings and is intended for the measurement of the following analytes: High Sensitivity Troponin-I (CTNI), CK-MB Mass (Creatine kinase. MB) (CKMB), Myoglobin (MYO), NT-proBNP (PBNP), D-dimer (DDMR), CardioPhase hsCRP (High Sensitiv
Siemens Healthcare Diagnostics Inc.
10444834
In Commercial Distribution

  • 00842768024863 ()
758000.901

  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
KIT TXMR X12 4-WIRE LONG AHA
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094272581 ()
10-00189-01

  • Electrocardiography telemetric monitoring system transmitter
Surveyor S12 GEN2 Patient Monitoring System - Surveyor Sp02, ECG, Dual Temp, NIBP, No IBP, resistive color touchscreen 11.6" display with 1366 x 768 resolution, AC or lithium ion rechargeable battery operation; International power cord; AM12 Wired Acquisition Module with AHA 12-lead lead set with snap ends and 1 IEC 5 wire ECG patient cable with clip ends; No invasive blood pressure cable; No cardiac output cable; Internal thermal printer (includes starter pack of thermal paper roll, 1.97 in. x
WELCH ALLYN, INC.
901138
In Commercial Distribution

  • 00732094327090 ()
SUR12-TDH-XXAAX

  • Electrocardiography telemetric monitoring system transmitter
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