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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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CareLink SmartSync™ Common Application - 00643169833739

SW M01A02 CARELINK SMARTSYNC IOS
MEDTRONIC, INC.
M01A02
In Commercial Distribution

  • 00643169833739 ()


  • Implantable cardiac device management application software

CareLink SmartSync™ Common Application - 00643169833715

SW M01G02 CARELINK SMARTSYNC ANDROID
MEDTRONIC, INC.
M01G02
In Commercial Distribution

  • 00643169833715 ()


  • Implantable cardiac device management application software

CareLink® Network - 00643169878075

SW CLN10 CARELINK NETWORK RELEASE
MEDTRONIC, INC.
CLN10
Not in Commercial Distribution

  • 00643169878075 ()


  • Implantable cardiac device management application software

CareLink® Network - 00643169878068

SW CLN09 CARELINK NETWORK RELEASE
MEDTRONIC, INC.
CLN09
Not in Commercial Distribution

  • 00643169878068 ()


  • Implantable cardiac device management application software

Merlin™ - 05415067037121

2 PCS MER3400 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
MER3400
In Commercial Distribution

  • 05415067037121 ()
MER3400

  • Implantable cardiac device management application software

Merlin™ - 05414734509725

PCS 3330 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
3330
In Commercial Distribution

  • 05414734509725 ()
3330

  • Implantable cardiac device management application software

myMerlinPulse™ - 05415067032829

Mobile application compatible to iOS operating system
ST. JUDE MEDICAL, INC.
APP1005
In Commercial Distribution

  • 05415067032829 ()
APP1005

  • Implantable cardiac device management application software

myMerlinPulse™ - 05415067032812

Mobile application compatible to Android operating system
ST. JUDE MEDICAL, INC.
APP1004
In Commercial Distribution

  • 05415067032812 ()
APP1004

  • Implantable cardiac device management application software

Merlin™ - 05415067049575

Live Connect Remote Session Engine
ST. JUDE MEDICAL, INC.
MLC1000
In Commercial Distribution

  • 05415067049575 ()
MLC1000

  • Implantable cardiac device management application software

CareLink® Network - 00643169731004

SW CLN07 CARELINK NETWORK RELEASE
MEDTRONIC, INC.
CLN07
Not in Commercial Distribution

  • 00643169731004 ()


  • Implantable cardiac device management application software

Fisher & Paykel Healthcare - 09420012424990

INFOSMART CD
FISHER & PAYKEL HEALTHCARE LIMITED
900SW100
In Commercial Distribution

  • 09420012424990 ()
900SW100

  • Ventilator application software

Water Phantom, 25 cm - 10815411020755

No Description
NEUROLOGICA CORP.
10-01527-001
Not in Commercial Distribution

  • 10815411020755 ()


  • CT phantom, test object

K-BALL - 03701313007942

K-BALL
S.M.A.I.O
01BK0001
In Commercial Distribution

  • 03701313007942 ()
01BK0001

  • CT phantom, test object

Sonata® SMART Tablet - 10817929020197

Ultrasound -guided intrauterine electrosurgical system ultrasound control unit
Gynesonics, Inc.
USCON-2200
In Commercial Distribution

  • 10817929020197 ()
USCON-2200

  • Ultrasound-guided intrauterine radio-frequency ablation system ultrasound control unit

ResScan - 00840193400191

ResScan v7.0
RESMED CORP.
31337
In Commercial Distribution

  • 00840193400191 ()


  • Ventilator application software

AirView - 00840193400108

AirView
RESMED CORP.
22240
In Commercial Distribution

  • 00840193400108 ()
22240

  • Ventilator application software

RMDpulse - 00840193400030

RMDpulse (iOS)
RESMED CORP.
22253
In Commercial Distribution

  • 00840193400030 ()


  • Ventilator application software

RMDpulse - 00840193400023

RMDpulse (Android)
RESMED CORP.
22254
In Commercial Distribution

  • 00840193400023 ()


  • Ventilator application software

ResScan - 08401934313396

ResScan V7.0.2
RESMED CORP.
31339
In Commercial Distribution

  • 08401934313396 ()


  • Ventilator application software

ResScan - 08401934313389

ResScan v7.0.1
RESMED CORP.
31338
In Commercial Distribution

  • 08401934313389 ()


  • Ventilator application software
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