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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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DreamMapper App iOS (APAC) - 00606959049109

DreamMapper iOS APAC Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution

  • 00606959049109 ()
1127959

  • Self-care monitoring/reporting software

DreamMapper App iOS (EMEA) - 00606959049093

DreamMapper iOS EU Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution

  • 00606959049093 ()
1128264

  • Self-care monitoring/reporting software

CONTOUR® DIABETES APP - 00301933537015

Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3537
In Commercial Distribution

  • 00301933537015 ()
85498754

  • Self-care monitoring/reporting software

CONTOUR® DIABETES APP - 00301933536018

Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3536
In Commercial Distribution

  • 00301933536018 ()
85498770

  • Self-care monitoring/reporting software

Asthma Monitor AMOS app - 04057155000603

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

  • 04057155000603 ()


  • Expiratory peak flow meter, digital

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

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

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

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

Nucleus® Smart App - 09321502065764

Hearing Implant Software for iOS Devices
COCHLEAR LIMITED
P1861019
In Commercial Distribution

  • 09321502065764 ()
P2006651

  • Audiometric/hearing device software

Nucleus® Smart App - 09321502065757

Hearing Implant Software for Android Devices
COCHLEAR LIMITED
P1860864
In Commercial Distribution

  • 09321502065757 ()
P2006652

  • Audiometric/hearing device software

MMI App for iOS - 00850037806010

iOS smartphone application for MODD1 Insulin Delivery System, software version v1.X
Modular Medical, Inc.
MODD1 Insulin Delivery System
In Commercial Distribution

  • 00850037806010 ()
MTL-103

  • Ambulatory insulin infusion pump software, patient-dosing

RNA - 10851290002444

CC527 Multi-Level Carton
Rna Medical Division
CC527 Multi-Level
In Commercial Distribution

  • 10851290002444 ()
CC 527

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

RNA - 10851290002437

CC527 Level 3 carton
Rna Medical Division
CC527 Level 3
In Commercial Distribution

  • 10851290002437 ()
CC 527-3

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

RNA - 10851290002420

CC527 Level 2 Carton
Rna Medical Division
CC527 Level 2
In Commercial Distribution

  • 10851290002420 ()
CC 527-2

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

RNA - 10851290002413

CC527 Level 1 Carton
Rna Medical Division
CC527 Level 1
In Commercial Distribution

  • 10851290002413 ()
CC 527-1

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

Osseolive Dental - ECURL20M0250

Device Name: Curasan OSSEOLIVE® DENTAL lndications for Use: OSSEOLIVE® DENTAL is indicated for applications in oral and maxillofacial surgery and dentistry, including filling and/or reconstruction of multi-walled (artificial or degenerative) bone defects, e.g.: - Defects after the extirpation of bone cysts - Augmentation of an atrophied alveolar ridge - Sinus lift or sinus floor elevation (subantral augmentation) - Filling of alveolar defects after tooth extraction for preservation of the alveolar ridge - Filling of extraction defects to create an implant bed - Filling of two- or multi-walled bone pockets as well as the bi- and trifurcation defects - Defects after operative removal of retained teeth or corrective osteotomies
curasan AG
250-1000µm
In Commercial Distribution

  • ECURL20M0250 ()
  • ECURL20M02505 ()
5x2.0 cc

  • Dental bone matrix implant, synthetic

d-Nav® - 00860001044218

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

  • 00860001044218 ()


  • Calculator, programmable

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

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

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

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

Sklar - 10649111346149

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

  • 10649111346149 ()


  • Eyelid speculum, reusable

N/A - 00763000371470

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

  • 00763000371470 ()


  • 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

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

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

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 - 00763000287290

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

  • 00763000287290 ()


  • Multiple active implantable device programmer

MacroPor-Si+ 8.0 cc - 00813909013206

Synthetic bone void filler for orthopedic applications
NOVABONE PRODUCTS, LLC
NB2508SX
In Commercial Distribution

  • 00813909013206 ()

  • 8.0cc
NB2508SX

  • Bone matrix implant, synthetic, non-antimicrobial

Diatro•Hypoclean CC - 05999883586631

Diatro•Hypoclean CC hypochlorite cleaning concentrate is a stabilized and micro-filtered concentrated hypochlorite solution for intensive oxidative cleaning, rinsing and washing of hematology analyzers’ capillaries, tubing and chambers, removing blood component precipitates and lipoprotein deposits on all hematology analyzers.
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
D801
In Commercial Distribution

  • 15999883586638 ()
  • 05999883586631 ()

  • Total Volume: 100 Milliliter
D8011

  • Wash/cleaning solution IVD, automated/semi-automated system

CC Angled Abutment - 00850008541803

No Description
I3 IMPLANT LLC
i3CCAA
In Commercial Distribution

  • 00850008541803 ()


  • Dental implant suprastructure, temporary, preformed, reusable

CC Straight Abutment - 00850008541797

No Description
I3 IMPLANT LLC
i3CCSA
In Commercial Distribution

  • 00850008541797 ()


  • Dental implant suprastructure, temporary, preformed, reusable

MacroPor-Si+ 15.0 cc - 00813909011073

Synthetic bone void filler for orthopedic applications
NOVABONE PRODUCTS, LLC
NB2515
In Commercial Distribution

  • 00813909011073 ()

  • 15.0cc
NB2515

  • Bone matrix implant, synthetic, non-antimicrobial

MacroPor-Si+ 10.0 cc - 00813909011066

Synthetic bone void filler for orthopedic applications
NOVABONE PRODUCTS, LLC
NB2510
In Commercial Distribution

  • 00813909011066 ()

  • 10.0cc
NB2510

  • Bone matrix implant, synthetic, non-antimicrobial

MacroPor-Si+ 8.0 cc - 00813909011059

Synthetic bone void filler for orthopedic applications
NOVABONE PRODUCTS, LLC
NB2508
In Commercial Distribution

  • 00813909011059 ()

  • 8.0cc
NB2508

  • Bone matrix implant, synthetic, non-antimicrobial
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