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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G5 Mobile Android App Stand Alone Software
Dexcom, Inc.
SW10940
In Commercial Distribution

  • 00386270000293 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
G5 Mobile IOS App Stand Alone Software
Dexcom, Inc.
SW10611
In Commercial Distribution

  • 00386270000002 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
for iOS
COCHLEAR LIMITED
NSA-1 / v5
In Commercial Distribution

  • 09321502062206 ()
P1834114

  • Audiometric/hearing device software
for Android
COCHLEAR LIMITED
NSA-2 / v5
In Commercial Distribution

  • 09321502062190 ()
P1834165

  • Audiometric/hearing device software
for iOS
COCHLEAR LIMITED
NSA-1 / v4
In Commercial Distribution

  • 09321502060486 ()
P1787372

  • Audiometric/hearing device software
for Android
COCHLEAR LIMITED
NSA-2 / v4
In Commercial Distribution

  • 09321502060479 ()
P1787373

  • Audiometric/hearing device software
No Description
Boston Brace International, Inc.
SENSOR-MA-V1
In Commercial Distribution

  • 00860013109813 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
No Description
NFANT LABS LLC
1
In Commercial Distribution

  • 00861410000246 ()
NA4

  • Biofeedback system application software
Eko mobile app for Android platforms for use with Eko products.
Eko Devices, Inc.
1.2.9
In Commercial Distribution

  • 00863609000341 ()


  • Medical equipment clinical data interfacing software
iOS mobile device software for use with Eko products.
Eko Devices, Inc.
3.1.1
In Commercial Distribution

  • 00863609000334 ()


  • Medical equipment clinical data interfacing software
The .decimal Astroid Dosimetry App device is used for planning and analysis of proton radiation therapy treatments.
DECIMAL, INC.
1.0
In Commercial Distribution

  • 00851147007076 ()


  • Radiation therapy software
Accessory to ERT's Asthma Monitor device for professional users
eResearchTechnology GmbH
2.x
In Commercial Distribution

  • 04057155000603 ()


  • Expiratory peak flow meter, digital
DreamMapper iOS APAC Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051355 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper iOS EU Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051348 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper iOS APAC Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049956 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper iOS EU Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049949 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper iOS APAC Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution

  • 00606959049109 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper iOS EU Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution

  • 00606959049093 ()
1128264

  • Self-care monitoring/reporting software
No Description
CURBELL MEDICAL PRODUCTS, INC.
Rego Safe Mobility App
In Commercial Distribution

  • 00840828192095 ()


  • Inpatient motion surveillance software
For the wireless mode version of the subject device, to be used in combination with an application installed on a tablet, the SPM01K3 convenience kit includes: 1 electrostimulator SPM01M1 configuration; electrodes; protective skin, and 1 tablet with the MySPM mobile application (SPM01A1).
NCS LAB SRL
SPM01K3
In Commercial Distribution

  • 08051122040964 ()
SPM01K3

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
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