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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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CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood from the fingertip, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek® PA, CardioChek Plus or CardioChek Plus Home Self-Test analyzer.
POLYMER TECHNOLOGY SYSTEMS, INC.
REF 4749
In Commercial Distribution

  • 00381934749013 ()
REF 4749

  • Multiple lipid analyte IVD, kit, spectrophotometry
CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood from the fingertip, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek® PA, CardioChek Plus or CardioChek Plus Home Self-Test analyzer.
POLYMER TECHNOLOGY SYSTEMS, INC.
REF 4747
In Commercial Distribution

  • 10381934747016 ()
  • 00381934747019 ()
REF 4747

  • Multiple lipid analyte IVD, kit, spectrophotometry
The portable and fully digital X-ray system Amadeo M-DR mini is for use for first aid services, intensive care units, emergency departments, as well as ships and mobile hospitals (e.g. container solutions) in inaccessible areas, in laboratories and scientific stations in remote parts of the world. The Amadeo M-DR mini is used for wireless digital X-ray imaging.
Oehm und Rehbein GmbH
Amadeo M-DR mini with Varex flat panel detector
Not in Commercial Distribution

  • 04250802902934 ()
  • 04250802902903 ()

  • Weight: 79 Kilogram
AM1722

  • Mobile basic diagnostic x-ray system, digital
The Discovery RF180 is a floor-mounted radiographic, fluoroscopic and linear tomographic system that consists of a 90/90 universal remote-controlled table with variable height, an R&F panel connected to a digital system and a voltage generator.
GENERAL MEDICAL MERATE SPA
Discovery RF180
In Commercial Distribution

  • 08054890480109 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
The CLISIS SYSTEMS is a floor-mounted radiographic, fluoroscopic and linear tomographic system that consists of a 90/90 universal remote-controlled table with variable height, an R&F panel connected to a digital system and a voltage generator.
GENERAL MEDICAL MERATE SPA
CLISIS SYSTEMS
In Commercial Distribution

  • 08054890480055 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
Xpert Flu kit; 10 test kit
CEPHEID
GXFLU-10A
Not in Commercial Distribution

  • 07332940001070 ()
GXFLU-10A

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in the calibration of the Randox Drugs of Abuse Panel on the Evidence® analyser.
RANDOX LABORATORIES LIMITED
EV3550
In Commercial Distribution

  • 05055273202458 ()
EV3550

  • Multiple drugs of abuse IVD, calibrator
The EZ Lift PowerLift Beach Chair, Left Shoulder Panel Pad, 3 inch TLT (Tri Layer Technology) provide excellent pressure management and are used with STERIS General Surgical Tables.
STERIS CORPORATION
BF00010
In Commercial Distribution

  • 00724995203542 ()
BF00010

  • Operating table mattress, basic
The HarmonyAIR E-Series High Definition Single Light 43-inchwith Single Flat Panel Monitor, 13-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173142 ()
LEH24IN01

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Dual Light with Single Flat Panel Monitor, 20-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172886 ()
LES02NC02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
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