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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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Heart and Respiration Rate Monitoring System powered by EarlySense - 00887761985155

EarlySense Sensor Assembly
HILL-ROM, INC.
P200898
In Commercial Distribution

  • 00887761985155 ()
  • 00887761975729 ()


  • Patient monitoring system module, multifunction

Heart and Respiration Rate Monitoring System powered by EarlySense - 00887761981720

EarlySense Sensor Assembly
HILL-ROM, INC.
P211560
In Commercial Distribution

  • 00887761975705 ()
  • 00887761981720 ()
  • 00887761975712 ()


  • Patient monitoring system module, multifunction

Cadwell - 00840067103968

RIPmate Lock Cable
CADWELL INDUSTRIES, INC.
302522-200-1053
Not in Commercial Distribution

  • 00840067103968 ()

  • Length: 53 Inch


  • Home-use sleep apnoea recording system
  • Polysomnograph

BRAEBON Disposable RIP Belt - B14055770

Disposable belt intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
5577
In Commercial Distribution

  • B14055770 ()

  • Length: 115 Feet
5577

  • Pneumograph

BRAEBON 2-Foot Double Loop Effort Belt - B140052320

Belt for use with PVDF Respiratory effort sensor..
Braebon Medical Corporation
0523-2
In Commercial Distribution

  • B140052320 ()

  • Length: 2 Feet
0523-2

  • Pneumograph
  • Electrode/transducer strap, reusable

Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300) - 08809988780001

No Description
Xandar Kardian Korea Inc.
XK300
Not in Commercial Distribution

  • 08809988780001 ()


  • Multiple vital physiological parameter monitoring system, home-use

ExSpiron Pediatric PadSets - 00851540007161

A non-sterile, single use electrode set designed to be adhered across a patient's chest and connected to the ExSpiron Monitor for impedance pneumography. Consists of electrodes and lead wire to allow for impedance measurements across a chest cavity.
Senzime AB (Publ.)
Pediatric
In Commercial Distribution

  • 00851540007161 ()
RMI-53040

  • Monitoring spirometer, electrical

ExSpiron 2Xi - 00851540007147

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 PadSet via the ExSpiron Patient Cable, the ExSpiron 2Xi Monitor provides a measurement of a patient's respiratory parameters, while also incorporating alarms. The ExSpiron 2Xi Monitor can be integrated into a medical facility's nurse call system.
Senzime AB (Publ.)
RMI-54000
In Commercial Distribution

  • 00851540007147 ()
  • 00851540007154 ()


  • Monitoring spirometer, electrical

ExSpiron 1Xi - 00851540007055

Assembly designed to be integrated into medical facility infrastructure in order to trigger a nurse call alarm system. Designed to be used only with the ExSpiron 1Xi Monitor.
Respiratory Motion Inc.
Nurse Call Module
In Commercial Distribution

  • 00851540007055 ()
  • 00851540007079 ()
RMI-51155

  • Nurse call system

ExSpiron PadSets - 00851540007048

A non-sterile, single use electrode set designed to be adhered across a patient's chest and connected to the ExSpiron Monitor for impedance pneumography. Consists of electrodes and lead wire to allow for impedance measurements across a chest cavity.
Senzime AB (Publ.)
Adult
In Commercial Distribution

  • 00851540007048 ()
  • 00851540007116 ()
RMI-51110

  • Monitoring spirometer, electrical

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

PORTRAIT SpO2 P-SE01 - 00195278264824

PORTRAIT SpO2 P-SE FINAL DEVICE ASSEMBLY
GE Healthcare Finland Oy
P-SE01
In Commercial Distribution

  • 00195278264824 ()
2104044-001

  • Pulse oximeter probe/processor

PORTRAIT RR P-RR01 - 00195278264817

PORTRAIT RR P-RR FINAL DEVICE ASSEMBLY
GE Healthcare Finland Oy
P-RR01
In Commercial Distribution

  • 00195278264817 ()
2103567-001

  • Respiration rate signal processor/transmitter

PORTRAIT SpO2 P-W01 - 00195278264800

PORTRAIT SpO2 P-W FINAL DEVICE ASSEMBLY
GE Healthcare Finland Oy
P-W01
In Commercial Distribution

  • 00195278264800 ()
2096441-001

  • Pulse oximeter probe/processor

PORTRAIT SpO2 P-SP01 - 00195278264794

PORTRAIT SpO2 P-SP FINAL DEVICE ASSEMBLY
GE Healthcare Finland Oy
P-SP01
In Commercial Distribution

  • 00195278264794 ()
2104045-001

  • Pulse oximeter probe/processor

PORTRAIT RRP01 - 00195278223401

BODY-WORN RESP ELECTRODE PATCH
GE Healthcare Finland Oy
RRP01
In Commercial Distribution

  • 00195278229229 ()
  • 00195278223401 ()
  • 00195278699893 ()
5514119

  • Thoracic electrical impedance electrode array, single-use

PORTRAIT AAB01 - 00195278201980

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

  • 00195278201980 ()
5514165

  • Electrode/transducer strap, single-use

PORTRAIT SBT01 - 00195278120014

SENSOR BATTERY DEVICE ASSEMBLY
GE Healthcare Finland Oy
SBT01
In Commercial Distribution

  • 00195278366085 ()
  • 00195278120014 ()
2096442-001

  • Multiple vital physiological parameter monitoring system transceiver

Sibel Spacelabs Trek Chest Patch Adhesive - 00850064210248

No Description
Sibel Health Inc.
900-00062
In Commercial Distribution

  • 00850064210248 ()


  • Wearable multiple physiological parameter recorder, reusable

Sibel Spacelabs Trek Chest Patch - 00850064210200

No Description
Sibel Health Inc.
900-00039
In Commercial Distribution

  • 00850064210200 ()


  • Wearable multiple physiological parameter recorder, reusable

ANNE Chest Sensor - 00850064210149

No Description
Sibel Health Inc.
810-00012
In Commercial Distribution

  • 00850064210149 ()


  • Wearable multiple physiological parameter recorder, reusable
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