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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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Near Infrared phototherapy device emitting up to 45 W at 980 nm, 12.1 Inch LCD Touch Screen display
Fotonmedix Medical Laser Co., LTD
LaserMedix4500U1
In Commercial Distribution

  • 06976487170007 ()


  • Musculoskeletal/physical therapy laser, professional
ISolate Ready to Use Density Gradient Medium at Two Concentrations. Contains 1x100mL Upper Layer and 1x100mL Lower Layer.
IRVINE SCIENTIFIC, LLC
99264-2x100ML
In Commercial Distribution

  • 00810195240361 ()
99264

  • IVF medium
ISolate Ready to Use Density Gradient Medium at Two Concentrations. Contains 6x6mL Upper Layer and 6x6mL Lower Layer.
IRVINE SCIENTIFIC, LLC
99264-12x6ML
In Commercial Distribution

  • 00810195240354 ()
99264

  • IVF medium
For patients breathing spontaneously via an ET tube or a tracheostomy tube in the hospital or at home.
Atos Medical AB
7723
In Commercial Distribution

  • 07331791015854 ()
  • 07331791017100 ()
7723

  • Tracheostoma protective filter
For patients breathing spontaneously via an ET tube or a tracheostomy tube in the hospital or at home.
Atos Medical AB
7707
In Commercial Distribution

  • 07331791016738 ()
  • 07331791009693 ()
7707

  • Tracheostoma protective filter
For patients breathing spontaneously via an ET tube or a tracheostomy tube in the hospital or at home.
Atos Medical AB
7704
In Commercial Distribution

  • 07331791016721 ()
  • 07331791002861 ()
7704

  • Tracheostoma protective filter
The First Device featuring PRISM Technology. Global patent including US Patent No. US 7.841.224 B2 & US 8.250.900 B2, Accuracy: +/- 0.01 at 0.10 g/dL (%BAC), Sensor module must be replaced every 200 tests or at least once yearly, whichever comes first.
AK Globaltech Corp
SM6000
In Commercial Distribution

  • 00853464001089 ()
AKG SM6000

  • Alcohol breath analyser
Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person and adolescents age 18 through 21 years of age .It can be used at medical facilities or at home.
Jiangxi Aicare Medical Technology Co., Ltd.
X5
In Commercial Distribution

  • 06972480916383 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person and adolescents age 18 through 21 years of age .It can be used at medical facilities or at home.
Jiangxi Aicare Medical Technology Co., Ltd.
X8
In Commercial Distribution

  • 06972480913269 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person and adolescents age 18 through 21 years of age .It can be used at medical facilities or at home.
Jiangxi Aicare Medical Technology Co., Ltd.
X11
In Commercial Distribution

  • 06972480913054 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
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