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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App IOS 2.0.1. This database entry also covers the following minor/medium software updates: v2.0.2: (01)00860001471700(11)190807(10)202; v2.0.3: (01)00860001471700(11)190927(10)203; v2.0.4: (01)00860001471700(11)191014(10)204; v2.0.5: (01)00860001471700(11)191218(10)205; v2.0.6:(01)00860001471700(11)200227(10)206; v2.1.0: (01)00860001471700(11)200528(10)210; v2.2.1: (01)00860001471700(11)200729(10)221; v2.3.0: (01)00860001471700(11)201217(10)230; v2.3.1: (01)00860001471700(11)210205(10)231; v2.3.2: (01)00860001471700(11)210507(10)232
AMPLIFON SPA
2.0.1
In Commercial Distribution

  • 00860001471700 ()


  • Hearing aid/implant system remote control
Eversense NOW Remote Monitoring mobile application (iOS) is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information.
SENSEONICS, INCORPORATED
FG-5901-01-300
In Commercial Distribution

  • 00817491021267 ()
FG-5901-01-300

  • Implantable glucose monitoring system
No Description
Thought Technology Ltd.
SA4515
In Commercial Distribution

  • 07540191000630 ()


  • Psychophysiological biofeedback system
A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025100 ()
MLL-EG30001

  • Radiology information system application software
RMDpulse (iOS)
RESMED CORP.
22253
In Commercial Distribution

  • 00840193400030 ()


  • Ventilator application software
MasterScreen IOS
Jaeger Medical GmbH
V-176420-13
In Commercial Distribution

  • 04250892905259 ()
V-176420-13

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176450-13
In Commercial Distribution

  • 04250892905242 ()
176450-13

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176400
In Commercial Distribution

  • 04250892905235 ()
176400

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176400
Not in Commercial Distribution

  • 04250892902777 ()
176400

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176420-03
Not in Commercial Distribution

  • 04250892902760 ()
V-176420-03

  • Pulmonary function analysis system, adult
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