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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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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

9340 2WAY BALOON VALVE - 00817136024448

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

  • 00817136024448 ()
CR1819

  • Pulmonary function valve

MEDLINE - 10653160357568

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

  • 00653160357561 ()
  • 10653160357568 ()
DYNDV2571

  • 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

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 - 10653160373643

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

  • 00653160373646 ()
  • 10653160373643 ()
DYNDV2571A

  • Peripheral intravenous catheterization support kit

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

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

SonoNav™ - 00721902865565

SFTWR 9730780 KIT SONONAV APP - PLUS
MEDTRONIC NAVIGATION, INC.
9730780
In Commercial Distribution

  • 00721902865565 ()


  • Multi-purpose stereotactic surgery system

N/A - 00721902865558

SFTWR 9730897 KIT FUNCTIONAL APP - PLUS
MEDTRONIC NAVIGATION, INC.
9730897
In Commercial Distribution

  • 00721902865558 ()


  • Multi-purpose stereotactic surgery system

FrameLink™ - 00721902966460

SFTWR 9731128 KIT, FRAMELINK APP -PLUS
MEDTRONIC NAVIGATION, INC.
9731128
In Commercial Distribution

  • 00721902966460 ()


  • Multi-purpose stereotactic surgery system

CARESTREAM Image Suite - 60889971055989

IMAGE SUITE / V4 SW MEDICAL APP
CARESTREAM HEALTH, INC.
CARESTREAM Image Suite
In Commercial Distribution

  • 60889971055989 ()
1055987

  • Radiological PACS software

N/A - 00763000159092

SW APP A52200 GU PATIENT PERFICIO
MEDTRONIC, INC.
A52200
In Commercial Distribution

  • 00763000159092 ()


  • Multiple active implantable device programmer

N/A - 00763000159085

SW APP A51200 GU CLINICIAN PERFICIO
MEDTRONIC, INC.
A51200
In Commercial Distribution

  • 00763000159085 ()


  • Multiple active implantable device programmer

Guardian™ Connect App - 00763000158392

SFTWR CSS7200 GRDN IOS APP V3.2.1
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000158392 ()


  • Patient health record information system application software

StealthStation Cranial Software - 00763000125295

SFW 9735762 APP STEALTH S8 APPLICATION
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000125295 ()


  • Multi-purpose stereotactic surgery system

N/A - 00763000024024

SW APP A520 GU PATIENT CHRONIC
MEDTRONIC, INC.
A520
In Commercial Distribution

  • 00763000024024 ()


  • Multiple active implantable device programmer

N/A - 00763000024017

SW APP A510 GU CLINICIAN CHRONIC
MEDTRONIC, INC.
A510
In Commercial Distribution

  • 00763000024017 ()


  • Multiple active implantable device programmer

StealthStation - 00763000063177

SFW 9735762 APP STEALTH S8 APPLICATION
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000063177 ()


  • Multi-purpose stereotactic surgery system

StealthStation Cranial Software - 00763000368494

SFW 9735762 APP STEALTH S8 APPLICATION
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000368494 ()


  • Multi-purpose stereotactic surgery system

StealthStation Cranial Software - 00763000234867

SFW 9735762 APP STEALTH S8 APPLICATION
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000234867 ()


  • Multi-purpose stereotactic surgery system

N/A - 00763000287306

SW APP A72300 SCS PATIENT TRIALING
MEDTRONIC, INC.
A72300
In Commercial Distribution

  • 00763000287306 ()


  • Multiple active implantable device programmer

N/A - 00763000287276

SW APP A71300 SCS CLINICIAN TRIALING
MEDTRONIC, INC.
A71300
In Commercial Distribution

  • 00763000287276 ()


  • Multiple active implantable device programmer

Medtronic Navigation - 00763000456986

SFW 9735762 APP STEALTH S8 APPLICATION
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000456986 ()


  • Multi-purpose stereotactic surgery system

MiniMed™ Mobile - 00763000416676

SFTWR MMT-6102 AHCL APP 1.3.3 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000416676 ()


  • Self-care monitoring/reporting software

MiniMed ™ Mobile - 00763000416669

SFTWR MMT-6101 AHCL APP 1.3.2 ANDROID
MEDTRONIC MINIMED, INC.
MMT-6101
In Commercial Distribution

  • 00763000416669 ()


  • Self-care monitoring/reporting software

InPen Smart Insulin Delivery System - 00763000489960

SOFTWARE MMT-8061 INS PEN ANDROID APP
MEDTRONIC MINIMED, INC.
MMT-8061
In Commercial Distribution

  • 00763000489960 ()


  • Empty self-injector, mechanical

InPen Smart Insulin Delivery System - 00763000489953

SOFTWARE MMT-8060 INSULIN PEN IOS APP
MEDTRONIC MINIMED, INC.
MMT-8060
In Commercial Distribution

  • 00763000489953 ()


  • Empty self-injector, mechanical

SteathStation - 00763000532123

SW 9735762 APP STLTH S8 v2.0.1
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000532123 ()


  • Multi-purpose stereotactic surgery system

NA - 00763000517199

SW APP A52300 OASIS PATIENT GU
MEDTRONIC, INC.
A52300
In Commercial Distribution

  • 00763000517199 ()


  • Multiple active implantable device programmer

NA - 00763000517182

SW APP A51300 OASIS CLINICIAN GU
MEDTRONIC, INC.
A51300
In Commercial Distribution

  • 00763000517182 ()


  • Multiple active implantable device programmer

N/A - 00763000273668

SW APP A71100 SCS RESTORE CLINICIAN
MEDTRONIC, INC.
A71100
In Commercial Distribution

  • 00763000273668 ()


  • Multiple active implantable device programmer

MiniMed™ Mobile - 00763000943264

SFTWR MMT-6102 AHCL APP 2.6 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000943264 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000943257

SFTWR MMT-6101 AHCL APP 2.6 ANDROID
MEDTRONIC MINIMED, INC.
MMT-6101
In Commercial Distribution

  • 00763000943257 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000910150

SFTWR MMT-6102 AHCL APP 2.5 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000910150 ()


  • Self-care monitoring/reporting software

MiniMed ™ Mobile - 00763000910143

SFTWR MMT-6101 AHCL APP 2.5 ANDROID
MEDTRONIC MINIMED, INC.
MMT-6101
In Commercial Distribution

  • 00763000910143 ()


  • Self-care monitoring/reporting software

N/A - 00763000975029

SOFTWARE APP A610 DBS CLINICIAN V5.0
MEDTRONIC, INC.
A610
In Commercial Distribution

  • 00763000975029 ()


  • Multiple active implantable device programmer

MiniMed™ Mobile - 00763000968175

SFTWR MMT-6102 AHCL APP 2.7 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000968175 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000968168

SFTWR MMT-6101 AHCL APP 2.7 ANDROID
MEDTRONIC MINIMED, INC.
MMT-6101
In Commercial Distribution

  • 00763000968168 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000867638

SFTWR MMT-6102 AHCL APP 2.2 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000867638 ()


  • Self-care monitoring/reporting software

MiniMed ™ Mobile - 00763000867621

SFTWR MMT-6101 AHCL APP 2.2.1 ANDROID
MEDTRONIC MINIMED, INC.
MMT-6101
In Commercial Distribution

  • 00763000867621 ()


  • Self-care monitoring/reporting software

StealthStation S8 - 00763000852818

SFW 9735762 APP STEALTH S8 V2.1
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000852818 ()


  • Multi-purpose stereotactic surgery system

MiniMed™ Mobile - 00763000827793

Sftwr MMT-6102 AHCL 2.1.1 App iOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000827793 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000827786

SFTWR MMT-6101 AHCL 2.1.0 APP ANDROID
MEDTRONIC MINIMED, INC.
MMT-6101
In Commercial Distribution

  • 00763000827786 ()


  • Self-care monitoring/reporting software

N/A - 00763000612832

SW APP A90300 RECHAGER APPLICATION V2.0
MEDTRONIC, INC.
A90300
In Commercial Distribution

  • 00763000612832 ()


  • Multiple active implantable device programmer

OrthoFlex - 00190730002341

OrtFlx Com McLaughlin 022 L1/2 Rx -6º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-841
In Commercial Distribution

  • 00190730002341 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002303

OrtFlx Com McLaughlin 022 U4/5 Rx -7º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-830
In Commercial Distribution

  • 00190730002303 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730001962

OrtFlx Com McLaughlin 018 L1/2 Rx -6º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-741
In Commercial Distribution

  • 00190730001962 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730001924

OrtFlx Com McLaughlin 018 U4/5 Rx -7º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-730
In Commercial Distribution

  • 00190730001924 ()


  • Orthodontic bracket, plastic, single-use

Avalon - 00190730000644

Avalon Com Roth 022 L1/2 Rx -6º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
A22-841
In Commercial Distribution

  • 00190730000644 ()


  • Orthodontic bracket, plastic, single-use
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