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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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Omnipod (Dash) View APP - 10385081120272

Mobile App utilized in the PDM (Personal Device Manager) for Dash. Insulin pump secondary display. PDM Device 18239; app 41253
Insulet Corporation
1.3.1
In Commercial Distribution

  • 10385081120272 ()
18239

  • Ambulatory insulin infusion pump software, data-display

Omnipod (Dash) Display App. - 10385081120265

Mobile App utilized in the PDM (Personal Device Manager) for Dash Insulin pump secondary display. PDM Device 18239; app 41252
Insulet Corporation
1.3.1
In Commercial Distribution

  • 10385081120265 ()
18239

  • Ambulatory insulin infusion pump software, data-display

Eversense Mobile App Android - 00817491023537

Eversense CGM Mobile Application (Android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5502-02-300
In Commercial Distribution

  • 00817491023537 ()
FG-5502-02-300

  • Implantable glucose monitoring system

Eversense Mobile App iOS - 00817491023520

Eversense Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-02-300
In Commercial Distribution

  • 00817491023520 ()
FG-5501-02-300

  • Implantable glucose monitoring system

BabySat 3 Rx App - 00810099090079

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

  • 00810099090079 ()


  • Multiple vital physiological parameter monitoring system, home-use

myLUX™ Patient App - 00802526623110

For Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622929-120
Not in Commercial Distribution

  • 00802526623110 ()
2929

  • Implantable cardiac device management application software

myLUX™ Patient App - 00802526623103

for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622939-120
Not in Commercial Distribution

  • 00802526623103 ()
2939

  • Implantable cardiac device management application software

myLUX™ Patient App - 00802526618215

for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
2939
In Commercial Distribution

  • 00802526618215 ()
2939

  • Implantable cardiac device management application software

myLUX™ Patient App - 00802526618208

For Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
2929
In Commercial Distribution

  • 00802526618208 ()
2929

  • Implantable cardiac device management application software

myLUX™ patient app - 00802526607608

for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622925-100
In Commercial Distribution

  • 00802526607608 ()
622925-100

  • Implantable cardiac device management application software

eVu Senz App iOS - 07540191000623

No Description
Thought Technology Ltd.
SA4520
In Commercial Distribution

  • 07540191000623 ()


  • Psychophysiological biofeedback system

Guardian™ Connect App - 00763000381103

SFTWR CSS7200 GRDN MBL IOS V 4.1.0
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000381103 ()


  • Patient health record information system application software

E. coli H5 serum, 5 mL - 05713106544020

Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
54402
In Commercial Distribution

  • 05713106544020 ()
54402

  • Escherichia coli antigen IVD, antibody

d-Nav® - 00860001044218

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

  • 00860001044218 ()


  • Calculator, programmable

Beurer - 00850003500430

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

DreamMapper - 00606959054233

DreamMapper Mobile App Android, EMEA Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054233 ()
1128265

  • Self-care monitoring/reporting software

Irregular Rhythm Notification feature 2.0 - 00194252456781

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 2.0 - 00194252456774

Irregular Rhythm Notification feature Watch App (Version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00194252456774 ()


  • Self-care monitoring/reporting software

Panacea - 00092237623824

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

ASSURE Patient Application - 00840241600283

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 Application - 00840241600252

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

Medicon - 04046826203382

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

Sklar - 10649111346149

WIRE SPEC TEMP APP NASAL SD 2 INCHES
SKLAR CORPORATION
22-8824
In Commercial Distribution

  • 10649111346149 ()


  • Eyelid speculum, reusable

NA - 00763000632793

SW APP A820 TDD PATIENT PROG V2.X
MEDTRONIC, INC.
A820
In Commercial Distribution

  • 00763000632793 ()


  • Infusion pump programmer

NA - 00763000632786

SW APP A810 TDD CLINICIAN PROG V2.X
MEDTRONIC, INC.
A810
In Commercial Distribution

  • 00763000632786 ()


  • Infusion pump programmer

NA - 00763000970079

SW APP A52200 GU PATIENT MICRO EU MDR
MEDTRONIC, INC.
A52200
In Commercial Distribution

  • 00763000970079 ()


  • Multiple active implantable device programmer

NA - 00763000970062

SW APP A51200 GU CLINICIAN MICRO EU MDR
MEDTRONIC, INC.
A51200
In Commercial Distribution

  • 00763000970062 ()


  • Multiple active implantable device programmer

N/A - 00763000371463

SW APP A71400 SCS CLINICIAN CP NG RC
MEDTRONIC, INC.
A71400
In Commercial Distribution

  • 00763000371463 ()


  • Multiple active implantable device programmer

N/A - 00763000287290

SW APP A72200 SCS PATIENT NG PAIN PC
MEDTRONIC, INC.
A72200
In Commercial Distribution

  • 00763000287290 ()


  • Multiple active implantable device programmer

N/A - 00763000520083

SW APP A71200 SCS CLINICIAN NG PAIN PC
MEDTRONIC, INC.
A71200
In Commercial Distribution

  • 00763000520083 ()


  • Multiple active implantable device programmer

N/A - 00763000371470

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

  • 00763000371470 ()


  • Multiple active implantable device programmer

IVA Cage Ti - 08809557208752

Anterior Cervical Discectomy Fusion Titanium Cage L14 x W16 x H5 x A7
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557208752 ()

  • Height: 5 Millimeter
TAC.14160705

  • Metallic spinal fusion cage, non-sterile

IVA Cage Ti - 08809557208691

Anterior Cervical Discectomy Fusion Titanium Cage L12 x W14 x H5 x A7
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557208691 ()

  • Height: 5 Millimeter
TAC.12140705

  • Metallic spinal fusion cage, non-sterile

IVA Cage - 08809557207793

Anterior Cervical Discectomy Fusion Cage (Flat) L15 x W18 x H5 x A7
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557207793 ()
ACF.15180705

  • Bone-screw internal spinal fixation system, non-sterile

IVA Cage - 08809557207717

Anterior Cervical Discectomy Fusion Cage (Flat) L15 x W18 x H5 x A0
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557207717 ()
ACF.15180005

  • Bone-screw internal spinal fixation system, non-sterile

IVA Cage - 08809557207632

Anterior Cervical Discectomy Fusion Cage (Flat) L14 x W16 x H5 x A7
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557207632 ()
ACF.14160705

  • Bone-screw internal spinal fixation system, non-sterile

IVA Cage - 08809557207557

Anterior Cervical Discectomy Fusion Cage (Flat) L14 x W16 x H5 x A0
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557207557 ()
ACF.14160005

  • Bone-screw internal spinal fixation system, non-sterile

IVA Cage - 08809557207472

Anterior Cervical Discectomy Fusion Cage (Flat) L12 x W14 x H5 x A7
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557207472 ()
ACF.12140705

  • Bone-screw internal spinal fixation system, non-sterile

IVA Cage - 08809557207397

Anterior Cervical Discectomy Fusion Cage (Flat) L12 x W14 x H5 x A0
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557207397 ()
ACF.12140005

  • Bone-screw internal spinal fixation system, non-sterile

IVA Cage - 08809557207311

Anterior Cervical Discectomy Fusion Cage (Flat) L11 x W12 x H5 x A7
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557207311 ()
ACF.11120705

  • Bone-screw internal spinal fixation system, non-sterile
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