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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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Lutech - B299750LIC0

Multi-parameter patient monitor. 750-L-IC
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LIC0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LI0

Multi-parameter patient monitor. 750-L-I
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LI0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LCP0

Multi-parameter patient monitor. 750-L-C-P
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LCP0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LC0

Multi-parameter patient monitor. 750-L-C
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LC0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750L0

Multi-parameter patient monitor. 750-L
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750L0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Clear Guide ONE - B201CGONE0

No Description
CLEAR GUIDE MEDICAL, INC.
CGONE
In Commercial Distribution

  • B201CGONE1 ()
  • B201CGONE0 ()


  • Ultrasound imaging system application software

Ambra Health Mobile Application - AMBRMOBILEAPP0

Mobile Application version of Ambra Health. Not intended for diagnostic purposes.
Ambra Health
AMBRMOBILEAPP0
In Commercial Distribution

  • AMBRMOBILEAPP0 ()


  • Radiology information system

Ambra PACS - AMBRHEALTHSOLUTIONS0

No Description
Ambra Health
3.16.10.0
In Commercial Distribution

  • AMBRHEALTHSOLUTIONS0 ()


  • Radiology information system

Ambra PACS - AMBRAPACS0

No Description
Ambra Health
3.24
In Commercial Distribution

  • AMBRAPACS0 ()


  • Radiology information system

Dream Sock Monitoring System - Blue Mist - 00810099091212

The Dream Sock analyzes photoplethysmography data to identify instances when the infant’s pulse rate (PR) and/or oxygen saturation (SpO2) moves outside a preset range, and provides a notification to the caregiver, prompting them to assess the infant. The Dream Sock also displays the infant’s PR and SpO2 values to the caregiver and displays trends in these measured values, and their relationship to the preset ranges, over time. These PR and SpO2 notifications and displays on the Dream Sock are intended for use in infants who are 1 to 18 months of age and between 6 to 30 lbs.
Owlet Baby Care, Inc.
OSS 3.0-M1; OBL 3.0-M1
In Commercial Distribution

  • 00810099091212 ()


  • Multiple vital physiological parameter monitoring system, home-use
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