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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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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

Sonova Brand (multiple brand) - 07613389402513

Easy Line Remote 2.0 app
Sonova AG
088-0012-70
In Commercial Distribution

  • 07613389402513 ()
088-0012-70

  • Audiometric/hearing device software

Sonova Brand (multiple brand) - 07613389398700

Easy Line Remote 2.0 app
Sonova AG
088-0012-02
In Commercial Distribution

  • 07613389398700 ()
088-0012-02

  • Audiometric/hearing device software

CARDINAL HEALTH - 10197106899885

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLF
In Commercial Distribution

  • 50197106899883 ()
  • 10197106899885 ()
SBA11LLSLF

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

CARDINAL HEALTH - 10198956001312

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL7
In Commercial Distribution

  • 50198956001310 ()
  • 10198956001312 ()
SBA11LLSL7

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

CARDINAL HEALTH - 10197106767740

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLE
In Commercial Distribution

  • 50197106767748 ()
  • 10197106767740 ()
SBA11LLSLE

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

Perifit - 07109615470598

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

  • 07109615470598 ()


  • Pelvic floor muscle exerciser

CARDINAL HEALTH - 10197106436516

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLD
In Commercial Distribution

  • 50197106436514 ()
  • 10197106436516 ()
SBA11LLSLD

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

CARDINAL HEALTH - 10198956020597

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL8
In Commercial Distribution

  • 50198956020595 ()
  • 10198956020597 ()
SBA11LLSL8

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

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

Meridian Medical - 00815067040032

APP PUMP NO PRESSURE REGULATOR
COMPASS HEALTH BRANDS CORP.
1001
In Commercial Distribution

  • 30815067040033 ()
  • 00815067040032 ()


  • Alternating-pressure inflator

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 - 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 - 07613389431674

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

  • 07613389431674 ()
088-0015-02

  • Audiometric/hearing device software

SMART TSF - 00885556746387

MY TSF HOMECARE APP iOS
Smith & Nephew, Inc.
71075402
In Commercial Distribution

  • 00885556746387 ()
71075402

  • Wireless patient monitor/sensor reporting software, layperson-use

SMART TSF - 00885556808016

MY TSF HOMECARE APP ANDROID
Smith & Nephew, Inc.
71075403
In Commercial Distribution

  • 00885556808016 ()
71075403

  • Wireless patient monitor/sensor reporting software, layperson-use

CARDINAL HEALTH - 10195594797133

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL4
In Commercial Distribution

  • 50195594797131 ()
  • 10195594797133 ()
SBA11LLSL4

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

CARDINAL HEALTH - 10195594880149

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL5
In Commercial Distribution

  • 50195594880147 ()
  • 10195594880149 ()
SBA11LLSL5

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

N/A - 00763000520076

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

  • 00763000520076 ()


  • Multiple active implantable device programmer

N/A - 00763000041618

SW APP A620 DBS PATIENT
MEDTRONIC, INC.
A620
In Commercial Distribution

  • 00763000041618 ()


  • Multiple active implantable device programmer

N/A - 00763000275655

SW APP A90300 RECHAGER APPLICATION
MEDTRONIC, INC.
A90300
In Commercial Distribution

  • 00763000275655 ()


  • Multiple active implantable device programmer

CARDINAL HEALTH - 10195594959180

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLB
In Commercial Distribution

  • 50195594959188 ()
  • 10195594959180 ()
SBA11LLSLB

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

CARDINAL HEALTH - 10195594700973

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL3
In Commercial Distribution

  • 50195594700971 ()
  • 10195594700973 ()
SBA11LLSL3

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

CARDINAL HEALTH - 10195594541880

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLC
In Commercial Distribution

  • 50195594541888 ()
  • 10195594541880 ()
SBA11LLSLC

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

CARDINAL HEALTH - 10197106036471

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL6
In Commercial Distribution

  • 50197106036479 ()
  • 10197106036471 ()
SBA11LLSL6

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

N/A - 00613994377517

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

  • 00613994377517 ()


  • ENT stereotactic surgery system

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

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

N/A - 00643169491748

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

  • 00643169491748 ()


  • ENT stereotactic surgery system

3DIEMME RealGUIDE - 08050038830003

Mobile version
3DIEMME SRL
RealGUIDE APP
In Commercial Distribution

  • 08050038830003 ()


  • CAD/CAM software

Persona Medical - 00851362008087

IOS & Android based APP used to control Evok 1600 OTE/BTE device.
Persona Medical
Persona APP
In Commercial Distribution

  • 00851362008087 ()


  • Air-conduction hearing aid, behind-the-ear

RXEars - 00851362008025

IOS & Android based APP used to control RxEars RX7 BTE device.
Persona Medical
RxEars APP
In Commercial Distribution

  • 00851362008025 ()


  • Air-conduction hearing aid, behind-the-ear

Clarius Ultrasound Scanner - 07540205000403

No Description
Clarius Mobile Health Corp
App - Android
In Commercial Distribution

  • 07540205000403 ()
12-01-00004

  • Ultrasound imaging system application software
  • Radiological PACS software

Clarius Ultrasound Scanner - 07540205000397

No Description
Clarius Mobile Health Corp
App - iOS
In Commercial Distribution

  • 07540205000397 ()
12-01-00003

  • Ultrasound imaging system application software
  • Radiological PACS software

DryGuardians - 07350078445160

No Description
Pjama AB
DryGuardians App
In Commercial Distribution

  • 07350078445160 ()
4200

  • Incontinence sensor/alarm

MEDLINE - 10653160373643

IV START KIT W/ CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYNDV2571A
In Commercial Distribution

  • 00653160373646 ()
  • 10653160373643 ()
DYNDV2571A

  • Peripheral intravenous catheterization support kit

MEDLINE - 10653160360469

IV START KIT W/CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYNDV2591
In Commercial Distribution

  • 00653160360462 ()
  • 10653160360469 ()
DYNDV2591

  • Peripheral intravenous catheterization support kit

9340 2WAY BALOON VALVE - 00817136024448

9340 2W INFBAL VLV MRI APP
HANS RUDOLPH, INC.
9340
Not in Commercial Distribution

  • 00817136024448 ()
CR1819

  • Pulmonary function valve

Panacea - 00092237617700

DS Panacea Dlx APP Pump & Pad
COMPASS HEALTH BRANDS CORP.
DS-APP2-ADJP
In Commercial Distribution

  • 30092237617701 ()
  • 00092237617700 ()


  • Alternating-pressure bed mattress overlay system

Panacea - 00092237617670

DS Panacea APP Adj Pump & Dlx
COMPASS HEALTH BRANDS CORP.
DS-APP1-ADJP
In Commercial Distribution

  • 30092237617671 ()
  • 00092237617670 ()


  • Alternating-pressure bed mattress overlay system

Meridian Medical - 00081506704258

APP PAD W/HEAD & FOOT FLAPS
COMPASS HEALTH BRANDS CORP.
1002F
In Commercial Distribution

  • 30815067042556 ()
  • 00081506704258 ()


  • Alternating-pressure bed mattress overlay, reusable

TRUE MANAGER AIR - 00021292013196

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

  • 00021292013196 ()


  • Self-care monitoring/reporting software

MEDLINE - 10653160357568

IV START KIT W/ CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYNDV2571
In Commercial Distribution

  • 00653160357561 ()
  • 10653160357568 ()
DYNDV2571

  • Peripheral intravenous catheterization support kit

Medline Industries, Inc. - 10080196992980

IV START KIT W/CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYND74260
In Commercial Distribution

  • 10080196992980 ()
  • 40080196992981 ()
DYND74260

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

Baha - 09321502036399

Cochlear Baha Control App for Android
Cochlear Bone Anchored Solutions AB
95460
In Commercial Distribution

  • 09321502036399 ()
95460

  • Hearing aid/implant system remote control
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