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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 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

  • 00850038861292 ()


  • Multiple vital physiological parameter monitoring system, home-use
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

  • 00850038861230 ()


  • Multiple vital physiological parameter monitoring system, home-use
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

  • 00850038861056 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
Exo Imaging, Inc.
EW1001
In Commercial Distribution

  • 00850018318013 ()


  • Ultrasound imaging system application software
VistaScan™ Software 1.x.x
EMAGINE SOLUTIONS TECHNOLOGY LLC
1.x.x
In Commercial Distribution

  • 00850017464001 ()


  • Ultrasound imaging system application software
No Description
RESOUNDANT, INC.
3.0DKR
In Commercial Distribution

  • 00850011790199 ()
MREPLUSV3

  • MRI system application software
No Description
RESOUNDANT, INC.
MREplus 3.0.0WIN
Not in Commercial Distribution

  • 00850011790014 ()


  • MRI system application software
No Description
RESOUNDANT, INC.
MREplus 3.0.0DKR
Not in Commercial Distribution

  • 00850011790007 ()


  • MRI system application software
Inliant System, US, Full Package
Navigate Surgical Technologies Inc
900010-1
In Commercial Distribution

  • 00850049386111 ()
9000101

  • Surgical planning/navigation-enhancement system
Consumable - Fiducial Kit
Navigate Surgical Technologies Inc
900007-0
In Commercial Distribution

  • 00850049386029 ()
9000070

  • Surgical planning/navigation-enhancement system
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