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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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ADVANCED INSTRUMENTATIONS, INC.
CMS-1000FM
In Commercial Distribution

  • B510CMS1000FM1 ()


  • Centralized patient monitor
WinOMS Practice Management Software
CARESTREAM HEALTH, INC.
CS WinOMS
In Commercial Distribution

  • 60889978014576 ()
8014573

  • Physician-practice-management information system
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
Dream Sock Software App. The Dream Sock is intended for over-the-counter (OTC) use only in a home environment. It is not intended to provide notification for every episode of the unexpected occurrences of elevated or depressed PR or a low SpO2 level; rather, the Dream Sock is intended to provide a notification only when sufficient data are available for analysis. The notifications and associated data can be used to supplement the decision by caregivers to seek additional guidance for medical care of the infant. The Dream Sock is not intended to replace traditional methods of monitoring, diagnosis or treatment.
Owlet Baby Care, Inc.
3.0
In Commercial Distribution

  • 00810099090819 ()


  • Multiple vital physiological parameter monitoring system, home-use
BabySat unit composed of one base station, one sensor, two socks and the App. The BabySat 3 pulse oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse rate. It is indicated for spot-checking and/or continuous monitoring of well-perfused patients greater than one month old up to 18 months old and weighing between 6 and 30 lbs., in the home environment
Owlet Baby Care, Inc.
OSS 3.0-M1; OBL 3.0-M1
In Commercial Distribution

  • 00810099090086 ()
  • 00810099090192 ()
  • 10810099090199 ()


  • Multiple vital physiological parameter monitoring system, home-use
Babysat System Application.
Owlet Baby Care, Inc.
2.23.0
In Commercial Distribution

  • 00810099090079 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
Owlet Baby Care, Inc.
OSS 3.0-M1
In Commercial Distribution

  • 00810099090031 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
Owlet Baby Care, Inc.
OBL 3.0-M1
In Commercial Distribution

  • 00810099090024 ()


  • Multiple vital physiological parameter monitoring system, home-use
THD HRStation is an integrated proctological station mainly dedicated to the diagnosis of pathologies of the anal canal and specifically to the diagnosis of precancerous lesions. Thanks to the THD Procto Software, it allows the proctologist to have a unique, modular and expandable diagnostic system that, in addition to the realization of high resolution anoscopy, can also allow further diagnostic investigations such as anorectal manometry and Transanal ultrasound.
THD SPA
THD HRStation
In Commercial Distribution

  • 58051887042642 ()
800299

  • Ultrasound imaging system application software
KARL STORZ AIDA control
Karl Storz GmbH & Co. KG
20096020
In Commercial Distribution

  • 04048551342855 ()


  • Physician-practice-management information system
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