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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Babysat System Application.
Owlet Baby Care, Inc.
2.23.0
In Commercial Distribution

  • 00810099090079 ()


  • Multiple vital physiological parameter monitoring system, home-use
for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622925-100
In Commercial Distribution

  • 00802526607608 ()
622925-100

  • Implantable cardiac device management application software
For Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622929-120
Not in Commercial Distribution

  • 00802526623110 ()
2929

  • Implantable cardiac device management application software
for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622939-120
Not in Commercial Distribution

  • 00802526623103 ()
2939

  • Implantable cardiac device management application software
for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
2939
In Commercial Distribution

  • 00802526618215 ()
2939

  • Implantable cardiac device management application software
For Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
2929
In Commercial Distribution

  • 00802526618208 ()
2929

  • Implantable cardiac device management application software
SFTWR CSS7200 GRDN MBL IOS V 4.1.0
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000381103 ()


  • Patient health record information system application software
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
DreamMapper Mobile App Android, EMEA Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054233 ()
1128265

  • Self-care monitoring/reporting software
Hygieia d-Nav System Phone App - Android Operating System
HYGIEIA, INC.
V1m00b053d
In Commercial Distribution

  • 00860001044218 ()


  • Calculator, programmable
Ovy by Beurer Basal Thermometer with Ovy App
BEURER NORTH AMERICA, L.P.
OT20
In Commercial Distribution

  • 20850003500434 ()
  • 10850003500437 ()
  • 00850003500430 ()
790.70

  • Thermometric fertility analyser
DS Panacea APP Adj Pump & Deluxe Single Pad
COMPASS HEALTH BRANDS CORP.
DS-APP1-SYS
In Commercial Distribution

  • 30092237623825 ()
  • 00092237623824 ()


  • Alternating-pressure bed mattress overlay system
WIRE SPEC TEMP APP NASAL SD 2 INCHES
SKLAR CORPORATION
22-8824
In Commercial Distribution

  • 10649111346149 ()


  • Eyelid speculum, reusable
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
Lathbury cotton app 6" serr tip l/m
Medicon eG. Chirurgiemechaniker-Genossenschaft
955.62.60
In Commercial Distribution

  • 04046826203382 ()
955.62.60

  • Surgical tamp, reusable
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
SW APP A71200 SCS CLINICIAN NG PAIN PC
MEDTRONIC, INC.
A71200
In Commercial Distribution

  • 00763000520083 ()


  • 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 A72400 SCS CLINICIAN PP NG RC
MEDTRONIC, INC.
A72400
In Commercial Distribution

  • 00763000371470 ()


  • 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
US Dexcom Follow App for iOS, (mg/dL), v4
Dexcom, Inc.
SW10497
In Commercial Distribution

  • 00386270001931 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
US Dexcom Follow App for Android (mg/dL), v4
Dexcom, Inc.
SW10583
In Commercial Distribution

  • 00386270001917 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
WAG Premium Arm GEN5 No Qualcomm/Homedics BT App
WALGREEN CO.
897652
In Commercial Distribution

  • 00311917206974 ()
  • 10311917206971 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
DreamMapper Mobile App Android, Asia- Pacific Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054240 ()
1127960

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

  • 00606959054226 ()
1101479

  • 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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