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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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Widex - 05706069673579

BEYOND app Android version 1.1
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069673579 ()
5 300 0005 001

  • Hearing aid/implant system remote control

Widex - 05706069673562

BEYOND app iOS version 1.1
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069673562 ()
5 300 0004 001

  • Hearing aid/implant system remote control

WIDEX - 05706069779714

APP WIDEX REMOTE CARE ANDROID
Widex A/S
Remote Care 1.3.4
In Commercial Distribution

  • 05706069779714 ()
21035228

  • Hearing aid/implant system remote control

WIDEX - 05706069779707

APP WIDEX REMOTE CARE IOS
Widex A/S
Remote Care 1.3.4
In Commercial Distribution

  • 05706069779707 ()
21035227

  • Hearing aid/implant system remote control

Sony - 05714880199420

Sony | Hearing Control App WA
Ws Audiology Usa, Inc.
Sony | Hearing Control WA
In Commercial Distribution

  • 05714880199420 ()
21026345

  • Audiometric/hearing device software

N/A - 00721902865572

SFTWR 9730896 CRANIAL APP - PLUS
MEDTRONIC NAVIGATION, INC.
9730896
In Commercial Distribution

  • 00721902865572 ()


  • Multi-purpose stereotactic surgery system

N/A - 00643169738058

SW APP A901 COMM MANAGER
MEDTRONIC, INC.
A901
In Commercial Distribution

  • 00643169738058 ()


  • Multiple active implantable device programmer

N/A - 00643169738041

SW APP A710 SCS CLINICIAN
MEDTRONIC, INC.
A710
In Commercial Distribution

  • 00643169738041 ()


  • Multiple active implantable device programmer

Protekt Aire Replacement Pump - 05060488570377

Protekt Adjustable APP Pump Only
PROACTIVE MEDICAL PRODUCTS, LLC
80010-PUMP
In Commercial Distribution

  • 05060488570377 ()

  • Width: 13 Inch
  • Length: 7.5 Inch
  • Height: 9 Inch
80010-PUMP

  • Alternating-pressure bed mattress overlay system

Perifit - 03770014642226

Perifit Kegel Exerciser with App
X6 INNOVATIONS
Green Perifit
Not in Commercial Distribution

  • 03770014642226 ()


  • Pelvic floor muscle exerciser

Perifit - 03770014642004

Perifit Kegel Exerciser with App
X6 INNOVATIONS
Pink
Not in Commercial Distribution

  • 03770014642004 ()


  • Pelvic floor muscle exerciser

Panacea - 00092237617694

DS Replacement APP Pad (Double
COMPASS HEALTH BRANDS CORP.
DS-APP2
In Commercial Distribution

  • 30092237617695 ()
  • 00092237617694 ()


  • Alternating-pressure bed mattress overlay, reusable

Panacea - 00092237617687

DS Panacea APP & Pad Syst.,
COMPASS HEALTH BRANDS CORP.
DS-APP1-NADJP
In Commercial Distribution

  • 30092237617688 ()
  • 00092237617687 ()


  • Alternating-pressure bed mattress overlay system

American Bantex - 00092237602232

Genesis Deluxe APP Pump/Pad
COMPASS HEALTH BRANDS CORP.
APP-2000-GBN
In Commercial Distribution

  • 40092237602230 ()
  • 00092237602232 ()


  • Alternating-pressure bed mattress overlay system

American Bantex - 00092237602225

Genesis standard APP pump/pad
COMPASS HEALTH BRANDS CORP.
APP-1000-GBN
In Commercial Distribution

  • 40092237602223 ()
  • 00092237602225 ()


  • Alternating-pressure bed mattress overlay system

TRUE MANAGER AIR - 00021292013622

TRUE MANAGER AIR APP - Android
TRIVIDIA HEALTH, INC.
TRUE MANAGER AIR APP - Android
In Commercial Distribution

  • 00021292013622 ()


  • Self-care monitoring/reporting software

Homedics - 00031262071712

MY MASSAGE APP CONTROLLED CUSH
Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd.
MCS-1000HJ
In Commercial Distribution

  • 10031262071719 ()
  • 00031262071712 ()


  • Bed/chair electric massager

n.a. - 04048551054543

BARANY Noise App. w. olive
Karl Storz GmbH & Co. KG
130000
In Commercial Distribution

  • 04048551054543 ()


  • Audiometric-evaluation noise system

ARIAL - 00840948103018

Arial Web App Configured Tower.
Securitas Healthcare LLC
0850-173
In Commercial Distribution

  • 00840948103018 ()
0850-173

  • Desktop computer

Medicon - 04046826203399

Lathbury cotton app 6" regular
Medicon eG. Chirurgiemechaniker-Genossenschaft
955.62.80
In Commercial Distribution

  • 04046826203399 ()
955.62.80

  • Surgical tamp, reusable

Medicon - 04046826203375

Lathbury cotton app 6" triang
Medicon eG. Chirurgiemechaniker-Genossenschaft
955.62.20
In Commercial Distribution

  • 04046826203375 ()
955.62.20

  • Surgical tamp, reusable

Medicon - 04046826203368

Lathbury cotton app 6" triang
Medicon eG. Chirurgiemechaniker-Genossenschaft
955.62.00
In Commercial Distribution

  • 04046826203368 ()
955.62.00

  • Surgical tamp, reusable

Lingo - 00357599849009

Lingo Biosensor iOS App US
ABBOTT DIABETES CARE INC
78783-01
In Commercial Distribution

  • 00357599849009 ()
78783-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

DreamMapper Mobile App Android (APAC) - 00606959048553

DreamMapper Mobile App Android (APAC)
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048553 ()
1127960

  • Self-care monitoring/reporting software

DreamMapper Mobile App Android (EMEA) - 00606959048546

DreamMapper Mobile App Android (EMEA)
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048546 ()
1128265

  • Self-care monitoring/reporting software

DreamMapper Mobile App Android (DMM) - 00606959048539

DreamMapper Mobile App Android (DMM)
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048539 ()
1101479

  • Self-care monitoring/reporting software

CARDINAL HEALTH - 10888439768442

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL2
In Commercial Distribution

  • 50888439768440 ()
  • 10888439768442 ()
SBA11LLSL2

  • Laparoscopic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439686432

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL1
In Commercial Distribution

  • 50888439686430 ()
  • 10888439686432 ()
SBA11LLSL1

  • Laparoscopic surgical procedure kit, non-medicated, single-use

Medline - 10080196403905

SYSTEM,APP,AIRONE, 220 VOLT
MEDLINE INDUSTRIES, INC.
MSCAIRONE220
In Commercial Distribution

  • 10080196403905 ()
MSCAIRONE220

  • Alternating-pressure bed mattress overlay, reusable

CARDINAL HEALTH - 10888439463965

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLA
In Commercial Distribution

  • 50888439463963 ()
  • 10888439463965 ()
SBA11LLSLA

  • Laparoscopic surgical procedure kit, non-medicated, single-use

DreamMapper - 00606959057678

DreamMapper Mobile App Android (APAC)
Respironics, Inc.
DreamMapper Mobile App Android, Asia- Pacific Instance - 2
In Commercial Distribution

  • 00606959057678 ()
1127960

  • Self-care monitoring/reporting software

DreamMapper - 00606959057661

DreamMapper Mobile App Android (EMEA)
Respironics, Inc.
DreamMapper Mobile App Android EMEA, - 2
In Commercial Distribution

  • 00606959057661 ()
1128265

  • Self-care monitoring/reporting software

DreamMapper - 00606959057654

DreamMapper Mobile App Android (DMM)
Respironics, Inc.
DreamMapper Mobile App Android, North America Instance - 2
In Commercial Distribution

  • 00606959057654 ()
1101479

  • Self-care monitoring/reporting software

Dexcom G7 Wear OS Watch App - 00386270005175

G7 Wear OS Watch App
Dexcom, Inc.
SW14502
In Commercial Distribution

  • 00386270005175 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

N/A - 00613994377517

SOFTWARE 9733467 FUSION ENT APP
MEDTRONIC NAVIGATION, INC.
9733467
In Commercial Distribution

  • 00613994377517 ()


  • ENT stereotactic surgery system

Unitron - 07613389465013

Unitron Remote Plus 4.0 app
Unitron Hearing Division
088-5013
In Commercial Distribution

  • 07613389465013 ()
088-5013

  • Audiometric/hearing device software

Sonova Brand - 07613389432220

Easy Line Remote 3.0 app
Sonova AG
088-0015
In Commercial Distribution

  • 07613389432220 ()
088-0015

  • Audiometric/hearing device software

Sonova Brand - 07613389432213

Easy Line Remote 3.0 app
Sonova AG
088-0015-06
In Commercial Distribution

  • 07613389432213 ()
088-0015-06

  • Audiometric/hearing device software

Sonova Brand - 07613389431704

Easy Line Remote 3.0 app
Sonova AG
088-0015-19
In Commercial Distribution

  • 07613389431704 ()
088-0015-19

  • Audiometric/hearing device software

Sonova Brand - 07613389431698

Easy Line Remote 3.0 app
Sonova AG
088-0015-17
In Commercial Distribution

  • 07613389431698 ()
088-0015-17

  • Audiometric/hearing device software

Sonova Brand - 07613389431681

Easy Line Remote 3.0 app
Sonova AG
088-0015-04
In Commercial Distribution

  • 07613389431681 ()
088-0015-04

  • Audiometric/hearing device software

Sonova Brand - 07613389431674

Easy Line Remote 3.0 app
Sonova AG
088-0015-02
In Commercial Distribution

  • 07613389431674 ()
088-0015-02

  • Audiometric/hearing device software

Sonova Brand - 07613389431667

Easy Line Remote 3.0 app
Sonova AG
088-0015-18
In Commercial Distribution

  • 07613389431667 ()
088-0015-18

  • Audiometric/hearing device software

Sonova Brand - 07613389431650

Easy Line Remote 3.0 app
Sonova AG
088-0015-70
In Commercial Distribution

  • 07613389431650 ()
088-0015-70

  • Audiometric/hearing device software

Sonova Brand (multiple brand) - 07613389402575

Easy Line Remote 2.0 app
Sonova AG
088-0012
In Commercial Distribution

  • 07613389402575 ()
088-0012

  • Audiometric/hearing device software

Sonova Brand (multiple brand) - 07613389402568

Easy Line Remote 2.0 app
Sonova AG
088-0012-19
In Commercial Distribution

  • 07613389402568 ()
088-0012-19

  • Audiometric/hearing device software

Sonova Brand (multiple brand) - 07613389402551

Easy Line Remote 2.0 app
Sonova AG
088-0012-06
In Commercial Distribution

  • 07613389402551 ()
088-0012-06

  • Audiometric/hearing device software

Sonova Brand (multiple brand) - 07613389402544

Easy Line Remote 2.0 app
Sonova AG
088-0012-04
In Commercial Distribution

  • 07613389402544 ()
088-0012-04

  • Audiometric/hearing device software

Sonova Brand (multiple brand) - 07613389402537

Easy Line Remote 2.0 app
Sonova AG
088-0012-17
In Commercial Distribution

  • 07613389402537 ()
088-0012-17

  • Audiometric/hearing device software

Sonova Brand (multiple brand) - 07613389402520

Easy Line Remote 2.0 app
Sonova AG
088-0012-18
In Commercial Distribution

  • 07613389402520 ()
088-0012-18

  • Audiometric/hearing device software
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