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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Hygieia d-Nav System Phone App - Android Operating System
HYGIEIA, INC.
V1m00b053d
In Commercial Distribution

  • 00860001044218 ()


  • Calculator, programmable
Irregular Rhythm Notification feature iPhone App (Version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00194252456781 ()


  • Self-care monitoring/reporting software
Irregular Rhythm Notification feature Watch App (Version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00194252456774 ()


  • Self-care monitoring/reporting software
SW APP A52200 GU PATIENT MICRO EU MDR
MEDTRONIC, INC.
A52200
In Commercial Distribution

  • 00763000970079 ()


  • Multiple active implantable device programmer
SW APP A51200 GU CLINICIAN MICRO EU MDR
MEDTRONIC, INC.
A51200
In Commercial Distribution

  • 00763000970062 ()


  • Multiple active implantable device programmer
ASSURE patient app is a component of CareStation.
Kestra Medical Technologies, Inc.
80601-001
In Commercial Distribution

80601-001

  • Medical equipment clinical data interfacing software
ASSURE patient app is a component of CareStation.
Kestra Medical Technologies, Inc.
80429-003
In Commercial Distribution

80429-003

  • Medical equipment clinical data interfacing software
SW APP A71200 SCS CLINICIAN NG PAIN PC
MEDTRONIC, INC.
A71200
In Commercial Distribution

  • 00763000520083 ()


  • Multiple active implantable device programmer
SW APP A72400 SCS CLINICIAN PP NG RC
MEDTRONIC, INC.
A72400
In Commercial Distribution

  • 00763000371470 ()


  • Multiple active implantable device programmer
SW APP A71400 SCS CLINICIAN CP NG RC
MEDTRONIC, INC.
A71400
In Commercial Distribution

  • 00763000371463 ()


  • Multiple active implantable device programmer
SW APP A72200 SCS PATIENT NG PAIN PC
MEDTRONIC, INC.
A72200
In Commercial Distribution

  • 00763000287290 ()


  • Multiple active implantable device programmer
SW APP A820 TDD PATIENT PROG V2.X
MEDTRONIC, INC.
A820
In Commercial Distribution

  • 00763000632793 ()


  • Infusion pump programmer
SW APP A810 TDD CLINICIAN PROG V2.X
MEDTRONIC, INC.
A810
In Commercial Distribution

  • 00763000632786 ()


  • Infusion pump programmer
Software, Sonicare Power Tooth brush, Web download App Android
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988984 ()


  • Basic electric toothbrush
Software, Sonicare Power Tooth brush, Web download App iOS
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988977 ()


  • Basic electric toothbrush
Pressure PreventionBlank Product Description: Balanced Aire APP Mattress Custom
Drive Devilbiss Healthcare
BA9600-CUSTOM
In Commercial Distribution

  • 00822383577173 ()


  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable
DreamMapper Mobile App Android, North America Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054226 ()
1101479

  • Self-care monitoring/reporting software
DreamMapper Mobile App Android, Asia- Pacific Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054240 ()
1127960

  • Self-care monitoring/reporting software
Hygieia d-Nav System Phone App - Apple iOS Operating System
HYGIEIA, INC.
V1m00b054i
In Commercial Distribution

  • 00860001044201 ()


  • Calculator, programmable
1, Needle App 18ga x 20cm Brachytherapy Non-Waxed, St
STELLAR MEDICAL, LLC
NA-1820SQ-NWS
In Commercial Distribution

  • 00853162006416 ()


  • Radiological image marker, implantable
  • Brachytherapy injection needle
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