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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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ExSpiron 1Xi - 00851540007024

Insulated, reusable, medical grade electrical cord design to enable connection of the ExSpiron 1Xi to a mains electricity supply socket, with a NEMA 5-15P plug and an IEC 60320-C13 connector at either end.
Respiratory Motion Inc.
Power Cord, 10'
In Commercial Distribution

  • 00851540007024 ()
  • 00851540007109 ()
RMI-51250

  • Electrical mains power cable

ExSpiron 1Xi - 00851540007000

A noninvasive device designed to continuously measure a patient's tidal volume, minute ventilation, and respiratory rate via impedance pneumography. Designed to be connected to the ExSpiron 1Xi PadSet via the ExSpiron 1Xi Patient Cable, the ExSpiron 1Xi Monitor provides a measurement of a patient's respiratory parameters, while also incorporating alarms. The ExSpiron 1Xi Monitor can be integrated into a medical facility's nurse call system via the ExSpiron 1Xi Nurse Call Module.
Respiratory Motion Inc.
Monitor
In Commercial Distribution

  • 00851540007000 ()
  • 00851540007031 ()
RMI-51000

  • Monitoring spirometer, electrical

ExSpiron - 00851540007017

Noninvasive, insulated, electrical cable designed to connect the ExSpiron Monitor to the ExSpiron PadSet.
Respiratory Motion Inc.
Patient Cable, 8'
In Commercial Distribution

  • 00851540007017 ()
  • 00851540007093 ()
RMI-51130

  • Monitoring spirometer, electrical

Sleepiz One+ - 07649996477019

No Description
Sleepiz AG
1.0
In Commercial Distribution

  • 07649996477019 ()


  • Multiple vital physiological parameter monitoring system, home-use

SansaTM - G2331000020

No Description
Huxley Medical, Inc.
1000-02
In Commercial Distribution

  • G2331000020 ()


  • Wearable multiple physiological parameter recorder, reusable

SansaTM - G2331000010

No Description
Huxley Medical, Inc.
1000-01
In Commercial Distribution

  • G2331000010 ()


  • Wearable multiple physiological parameter recorder, reusable

SansaTM - G2331000000

No Description
Huxley Medical, Inc.
1000-00
In Commercial Distribution

  • G2331000000 ()


  • Wearable multiple physiological parameter recorder, reusable

Disposable Electrode Serie - 06924274950608

No Description
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
VIX-A015腔镜电极
In Commercial Distribution

  • 06924274950608 ()


  • Open-surgery electrosurgical electrode, monopolar, single-use

Healthweigh - 00850042373255

Scale, Digital Home Health Model DHH-10BT 440lb (200kg) x0.2lb (0.1kg) 300mm (L) x 360mm (W) x 8mm (H) includes (2) AAA batteries, tempered glass Includes Bluetooth connectivity compatible with Apple Health and Google Health APP
Rice Lake Weighing Systems, Inc.
DHH-10BT
In Commercial Distribution

  • 00850042373255 ()
201125

  • Stand-on floor scale, electronic

Stethee Pro Central Web Application - 09351356000055

Stethee Pro Central Web Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000055 ()


  • Phonocardiograph
  • Stethoscope application software

Stethee Pro Mobile iOS Application - 09351356000048

Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000048 ()


  • Phonocardiograph
  • Stethoscope application software

Stethee Pro Mobile Android Application - 09351356000031

Stethee Pro Mobile Android Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000031 ()


  • Phonocardiograph
  • Stethoscope application software

HindexRV - 00860001651911

The HindexRV® Monitoring System is a physiological monitoring device that collects and transmits measurements (heart rate, respiration rate and muscle activity) using sensors. The HindexRV® monitoring system monitors the sympathetic and parasympathetic nervous system using accurate recordings of heart rate (HR) from EKG and provides statistical data as well as heart rate variability (HRV) data.
HHS SYSTEMS, INC.
1
In Commercial Distribution

  • 00860001651911 ()
SA7525HHS

  • Multi-purpose invasive/noninvasive electrode kit
  • Psychophysiological biofeedback system
  • Electrocardiographic electrode, single-use
  • Electrocardiograph, professional, single-channel

HindexRV - 00860001651904

The HindexRV® Monitoring System is a physiological monitoring device that collects and transmits measurements (heart rate, respiration rate and muscle activity) using sensors. The HindexRV® monitoring system monitors the sympathetic and parasympathetic nervous system using accurate recordings of heart rate (HR) from EKG and provides statistical data as well as heart rate variability (HRV) data.
HHS SYSTEMS, INC.
1
In Commercial Distribution

  • 00860001651904 ()
SA7525HHS

  • Multi-purpose invasive/noninvasive electrode kit
  • Psychophysiological biofeedback system
  • Electrocardiographic electrode, single-use
  • Electrocardiograph, professional, single-channel

Spire Health Remote Patient Monitoring System - 00860008932204

The Spire Health Remote Patient Monitoring System (RPM) is designed to capture, process, and longitudinally track clinically relevant patient health data.
CONVEXITY SCIENTIFIC LLC
700099
In Commercial Distribution

  • 00860008932204 ()


  • Wearable multiple vital physiological parameter monitoring system

Glooko Mobile Insulin Dosing System (MIDS) Android & iOS Mobile Application - 00855093008002

Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems.
GLOOKO, INC.
5.x
In Commercial Distribution

  • 00855093008002 ()


  • Clinical management support software

Current Health Wearable Monnitoring System - 05060526847706

Current Health Wearable Monitoring System
CURRENT HEALTH LIMITED
G2
In Commercial Distribution

  • 05060526847706 ()
WD-A-001

  • General-purpose multi-parameter bedside monitor

Current Health Wearable Monnitoring System - 05060526840004

Current Health Wearable Monnitoring System (Gen 1 Wearable)
CURRENT HEALTH LIMITED
G1
In Commercial Distribution

  • 05060526840004 ()
40

  • General-purpose multi-parameter bedside monitor

Portrait HUBXB - 00195278713193

Portrait Mobile Patient Monitor Hardware HUBXB
GE Healthcare Finland Oy
HUBXB
In Commercial Distribution

  • 00195278713193 ()
5923524

  • Wearable multiple vital physiological parameter monitor

PORTRAIT MMP01 - 00195278699923

Portrait MMP01 Mobile Patient Monitor Pouch, PKG of 30 PCS
GE Healthcare Finland Oy
MMP01
In Commercial Distribution

  • 00195278699923 ()
5514246-30

  • Personal device holder, single-use

PORTRAIT AAB01 - 00195278699916

Portrait AAB01 SpO2 attachment accessory band, PKG of 30 PCS
GE Healthcare Finland Oy
AAB01
In Commercial Distribution

  • 00195278699916 ()
5514165-30

  • Electrode/transducer strap, single-use

PORTRAIT HSWXB - 00195278697165

Portrait HSWXB Medical Software
GE Healthcare Finland Oy
HSWXB
In Commercial Distribution

  • 00195278697165 ()
5700219-11

  • Physiologic monitor-installed software

Portrait CSSXB - 00195278659446

PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.1.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CSSXB
In Commercial Distribution

  • 00195278659446 ()
5933539

  • Bedside information system application software

PORTRAIT MMP01 - 00195278110435

Portrait MMP01 Mobile Patient Monitor Pouch, PKG of 30 PCS
GE Healthcare Finland Oy
MMP01
In Commercial Distribution

  • 00195278110435 ()
5514246

  • Personal device holder, single-use

PORTRAIT BCH01 - 00195278094001

CHARGER, AMBULATORY CHARGER FINAL DEVICE ASSEMBLY
GE Healthcare Finland Oy
BCH01
In Commercial Distribution

  • 00195278094001 ()
2096439-001

  • Noninvasive device battery charger

PORTRAIT HUB01 - 00195278093998

HUB, AMBULATORY HUB DEVICE ASSEMBLY
GE Healthcare Finland Oy
HUB01
In Commercial Distribution

  • 00195278093998 ()
2096437-001

  • Wearable multiple vital physiological parameter monitor

Portrait CVAXB - 00195278656681

Portrait Central Viewer Application Installer v1.1.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVAXB
In Commercial Distribution

  • 00195278656681 ()
5863721-11

  • Wireless patient monitor/sensor reporting software, professional-only

Portrait CSS01 - 00195278341129

PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.0.3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CSS01
In Commercial Distribution

  • 00195278341129 ()
5870857

  • Bedside information system application software

Portrait CVA01 - 00195278330413

PORTRAIT CENTRAL STATION INSTALLATION SOFTWARE V1.0.2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVA01
In Commercial Distribution

  • 00195278330413 ()
5863721

  • Wireless patient monitor/sensor reporting software, professional-only

PORTRAIT SpO2 P-SA01 - 00195278264831

PORTRAIT SpO2 P-SA FINAL DEVICE ASSEMBLY
GE Healthcare Finland Oy
P-SA01
In Commercial Distribution

  • 00195278264831 ()
2103502-001

  • Pulse oximeter probe/processor
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