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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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UltraSPECT - 00850040177015

WBR Imaging X3
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177015 ()


  • SPECT system application software

UltraSPECT - 00850040177008

WBR Imaging X
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177008 ()


  • SPECT system application software

Dream Sock Monitoring System - Sweet Clementine (Duo) - 00850038861711

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

  • 00850038861711 ()


  • Multiple vital physiological parameter monitoring system, home-use

Dream Sock Monitoring System - Bedtime Blue (Duo) - 00850038861292

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

Dream Sock Monitoring System - Mint (Duo) - 00850038861056

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

AcQMap - 00857042007999

AcQMap System
ACUTUS MEDICAL, INC.
900000
Not in Commercial Distribution

  • 00857042007999 ()
900000

  • Cardiac mapping system

AcQMap - 00857042007920

AcQMap System Console 2.0
ACUTUS MEDICAL, INC.
900100
Not in Commercial Distribution

  • 00857042007920 ()
900100

  • Cardiac mapping system

AcQMap - 00857042007326

AcQMap Ablation Reference Cable
ACUTUS MEDICAL, INC.
800505
Not in Commercial Distribution

  • 00857042007326 ()
800505

  • Cardiac mapping system

AcQMap - 00857042007319

AcQMap Ablation Electrogram Cable
ACUTUS MEDICAL, INC.
800508
Not in Commercial Distribution

  • 00857042007319 ()
800508

  • Cardiac mapping system

AcQMap - 00857042007302

AcQMap Auxiliary Interface Box
ACUTUS MEDICAL, INC.
800422
Not in Commercial Distribution

  • 00857042007302 ()
800422

  • Cardiac mapping system
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