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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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A Health Harmony Kit contains the components of the Health Harmony Remote Patient Monitoring system that are needed by the patient. A Health Harmony Hub Kit is for patients that do not use the Health Harmony Mobile application. (This is a viable option when the collection of vital signs alone provides adequate information for the clinician to remotely manage the patient.) The kit contains an interface hub device and any Bluetooth medical devices (e.g. a weight scale or a pulse oximeter) that have been selected by the healthcare provider for remote collection of patient vital signs.
Care Innovations, LLC
Kit RPM - Hub
Not in Commercial Distribution

  • 00850040853056 ()


  • Multiple physiological parameter spot-check system, home-use
A Health Harmony Kit contains the components of the Health Harmony Remote Patient Monitoring system that are needed by the patient. A Health Harmony BYOD Kit is for patients that download and use the Health Harmony Mobile application on their own personal mobile device. The kit will contain any Bluetooth medical devices (e.g. a weight scale or a pulse oximeter) that have been selected by the healthcare provider for remote collection of patient vital signs.
Care Innovations, LLC
Kit RPM - BYOD
Not in Commercial Distribution

  • 00850040853049 ()


  • Multiple physiological parameter spot-check system, home-use
A Health Harmony Kit contains the components of the Health Harmony Remote Patient Monitoring system that are needed by the patient. A Health Harmony Mobile Kit contains a personal mobile device pre-loaded with Health Harmony Mobile software that has been setup for the patient. The kit will also contain any Bluetooth medical devices (e.g. a weight scale or a pulse oximeter) that have been selected by the healthcare provider for remote collection of patient vital signs.
Care Innovations, LLC
Kit RPM - Mobile
Not in Commercial Distribution

  • 00850040853032 ()


  • Multiple physiological parameter spot-check system, home-use
The All-in-One Health Monitor is a device designed for measuring the patient’s physiological parameters, such as Non-Invasive Blood Pressure (NIBP), Oxygen saturation (SpO2), Pulse Rate (PR) and Body Temperature (TEMP).
GLOBALMEDIA GROUP, LLC
Dual - BT & USB
In Commercial Distribution

  • 00850033167160 ()
GMR50700030

  • Multiple physiological parameter spot-check system, clinical
The All-in-One Health Monitor is a device designed for measuring the patient’s physiological parameters, such as Non-Invasive Blood Pressure (NIBP), Oxygen saturation (SpO2), Pulse Rate (PR) and Body Temperature (TEMP).
GLOBALMEDIA GROUP, LLC
USB
In Commercial Distribution

  • 00850033167146 ()
GMR50700010

  • Multiple physiological parameter spot-check system, clinical
PROBE 61399400072 10BX TEMPERATURE
MEDTRONIC, INC.
61399400072
In Commercial Distribution

  • 20885074286147 ()
  • 00885074286143 ()


  • General-purpose patient temperature probe, reusable
Foley Catheter Temperature Probe Disposable; size = 14Fr; probe length = 17" (43cm); sterile; minimum shelf life = 12 months; 1 cs = 10 probes; wgt = 1 lb (454g)
Philips Medical Systems Hsg
Foley Catheter Temperature Probe
Not in Commercial Distribution

  • 20884838008650 ()
  • 00884838008656 ()
M2255A

  • General-purpose patient temperature probe, single-use
Foley Catheter Temperature Probe Disposable; size = 18 Fr; probe length = 17" (43cm); sterile; minimum shelf life = 12 months; 1 cs = 10 probes; wgt = 1 lb (454g)
Philips Medical Systems Hsg
Foley Catheter Temperature Probe
Not in Commercial Distribution

  • 20884838006922 ()
  • 00884838006928 ()
21097A

  • General-purpose patient temperature probe, single-use
Foley Catheter Temperature Probe Disposable; size = 16Fr; probe length = 17" (43cm); sterile; minimum shelf life = 12 months; 1cs = 10 probes; wgt = 1lb (454g)
Philips Medical Systems Hsg
Foley Catheter Temperature Probe
Not in Commercial Distribution

  • 20884838006915 ()
  • 00884838006911 ()
21096A

  • General-purpose patient temperature probe, single-use
Esophageal/Stethoscope Temperature Probe Disposable; size = 24 Fr; probe length = 18" (46cm); sterile; minimum shelf life = 12 months; 1cs = 20 probes; wgt = 1lb (454g)
Philips Medical Systems Hsg
Esophageal/Stethoscope Temperature Probe
Not in Commercial Distribution

  • 20884838006908 ()
  • 00884838006904 ()
21095A

  • General-purpose patient temperature probe, single-use
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