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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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Happy Health - 00850068747115

No Description
HAPPY HEALTH, INC.
Happy Ring HR0801GB
In Commercial Distribution

  • 00850068747115 ()


  • Multiple vital physiological parameter monitoring system, home-use

Happy Health - 00850068747108

No Description
HAPPY HEALTH, INC.
Happy Ring HR0701GB
In Commercial Distribution

  • 00850068747108 ()


  • Multiple vital physiological parameter monitoring system, home-use

Happy Health - 00850068747092

No Description
HAPPY HEALTH, INC.
Happy Ring HR0601GB
In Commercial Distribution

  • 00850068747092 ()


  • Multiple vital physiological parameter monitoring system, home-use

Sibel Spacelabs Trek Tablet - 00850064210262

No Description
Sibel Health Inc.
900-00043
In Commercial Distribution

  • 00850064210262 ()


  • Wearable multiple vital physiological parameter monitor

Sibel Spacelabs Trek Charger - 00850064210224

No Description
Sibel Health Inc.
900-00046
In Commercial Distribution

  • 00850064210224 ()


  • Wearable multiple vital physiological parameter monitor

Central Hub Speaker - 00850064210194

Central Hub Speaker
Sibel Health Inc.
900-00004
In Commercial Distribution

  • 00850064210194 ()


  • Wearable multiple vital physiological parameter monitor

Central Hub CMS - 00850064210163

Central Hub CMS
Sibel Health Inc.
900-00013
In Commercial Distribution

  • 00850064210163 ()


  • Wearable multiple vital physiological parameter monitor

ANNE View Patient Monitor - 00850064210132

Patient monitor consisting of a mobile tablet and the ANNE View software. The ANNE View Patient Monitor connects to the ANNE Chest sensor, ANNE Limb sensor, and compatible devices for the real-time display of physiological data.
Sibel Health Inc.
900-00012
In Commercial Distribution

  • 00850064210132 ()


  • Wearable multiple vital physiological parameter monitor

7-Day ANNE Chest Adhesive Shelf Box - 00850064210101

Box of 30 7-Day adhesives for the ANNE Chest sensor.
Sibel Health Inc.
900-00010
In Commercial Distribution

  • 00850064210101 ()


  • Wearable multiple vital physiological parameter monitor

ANNE Bedside Wireless Charger - 00850064210057

Bedside charger for the ANNE Chest and ANNE Limb sensors.
Sibel Health Inc.
900-00008
In Commercial Distribution

  • 00850064210057 ()


  • Wearable multiple vital physiological parameter monitor
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