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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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The higi Station is intended for use by the general public to measure blood pressure, pulse, body weight, percent body fat, percent lean body mass, total body water and calculate body mass index. It is not a diagnostic device and only furnishes data so that users can consult their personal physician or other healthcare professional. The user can choose to store or send the data to a personal physician or healthcare professional. Users must be 13 years of age to use the higi Station.
HIGI SH LLC
ZT2776A0021
In Commercial Distribution

  • B146ZT2776A00210 ()
n/a

  • Automatic-inflation electronic sphygmomanometer, non-portable
The higi Station is intended for use by the general public to measure blood pressure, pulse, body weight, percent body fat, percent lean body mass, total body water and calculate body mass index. It is not a diagnostic device and only furnishes data so that users can consult their personal physician or other healthcare professional. The user can choose to store or send the data to a personal physician or healthcare professional. Users must be 13 years of age to use the higi Station.
HIGI SH LLC
1301252105
In Commercial Distribution

  • B416SH650 ()
n/a

  • Automatic-inflation electronic sphygmomanometer, non-portable
The higi Station is intended for use by the general public to measure blood pressure, pulse, body weight, percent body fat, percent lean body mass, total body water and calculate body mass index. It is not a diagnostic device and only furnishes data so that users can consult their personal physician or other healthcare professional. The user can choose to store or send the data to a personal physician or healthcare professional. Users must be 13 years of age to use the higi Station.
HIGI SH LLC
KMY-120630950-117
In Commercial Distribution

  • B416KMY8202F0 ()
n/a

  • Automatic-inflation electronic sphygmomanometer, non-portable
No Description
Csa Service Solutions
LC300WC
In Commercial Distribution

  • B468LC300WC0 ()


  • Automatic-inflation electronic sphygmomanometer, non-portable
No Description
Csa Service Solutions
LC300
In Commercial Distribution

  • B468LC300 ()


  • Automatic-inflation electronic sphygmomanometer, non-portable
No Description
BIOMERIEUX SA
500017
In Commercial Distribution

  • B0745000170 ()
500017

  • Fluorescent immunoassay analyser IVD, laboratory
No Description
BIOMERIEUX SA
400016
In Commercial Distribution

  • B0744000160 ()
400016

  • Fluorescent immunoassay analyser IVD, laboratory
Scanner S900 ARTI 230 V with scan- and basic modelling Software, PC and screen
ZIRKONZAHN SRL
SYAB0930
In Commercial Distribution

  • D800SYAB0930 ()


  • Dental milling system, CAD/CAM, laboratory
Scanner S600 ARTI 120 V with scan- and basic modelling software, PC and screen
ZIRKONZAHN SRL
SY0197
In Commercial Distribution

  • D800SY0197 ()


  • Dental milling system, CAD/CAM, laboratory
Scanner S600 ARTI 230 V with scan- and basic modelling Software, PC and screen
ZIRKONZAHN SRL
SY0161
In Commercial Distribution

  • D800SY0161 ()


  • Dental milling system, CAD/CAM, laboratory
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