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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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FCR 1Shot Phantom Plus - 04547410538861

1 Shot Phantom Plus is used for quality control of digital Radiography systems.
FUJIFILM CORPORATION
FCR 1SHOT PHANTOM PLUS MDR E
In Commercial Distribution

  • 04547410538861 ()


  • General-purpose diagnostic x-ray phantom, test object

AngelMed Guardian Programmer Wand EXD Model EXD-001 - 00850012625070

PROG-003 Wand
Avertix Medical Inc.
0204-2100-067#P15
In Commercial Distribution

  • 00850012625070 ()
0204-2100-067#P15

  • Implantable cardiac monitor programmer/transmitter/alarm

AngelMed Guardian EXD Lanyard - 00850012625056

EXD Lanyard
Avertix Medical Inc.
0203-2100-003
In Commercial Distribution

  • 00850012625056 ()
0203-2100-003

  • Implantable cardiac monitor programmer/transmitter/alarm

AngelMed Guardian EXD Carrying Case - 00850012625049

EXD Carrying Case
Avertix Medical Inc.
0203-2100-004
In Commercial Distribution

  • 00850012625049 ()
0203-2100-004

  • Implantable cardiac monitor programmer/transmitter/alarm

AngelMed Guardian EXD Model EXD-001 - 00850012625032

EXD-001 Kit (Latin-American Spanish)
Avertix Medical Inc.
0203-2100-002-C4#P16
In Commercial Distribution

  • 00850012625032 ()
0203-2100-002-C4#P16

  • Implantable cardiac monitor programmer/transmitter/alarm

AngelMed Guardian EXD Model EXD-001 - 00850012625025

EXD-001 Kit
Avertix Medical Inc.
0203-2100-002#P16
In Commercial Distribution

  • 00850012625025 ()
0203-2100-002#P16

  • Implantable cardiac monitor programmer/transmitter/alarm

AED Manager, V.2.2.1.1 Powerheart G5 - 00812394021505

Event Reporting and Administrative AED Configuration Software V.2.2.1.1 for Powerheart G5
Zoll Medical Corporation
40-00296-05
In Commercial Distribution

  • 00812394021505 ()
40-00296-05

  • External defibrillator application software

Powerheart® MDLink - 00812394021499

MDLink SW 12.0
Zoll Medical Corporation
40-00580-01
In Commercial Distribution

  • 00812394021499 ()
40-00580-01

  • External defibrillator application software

Powerheart® MDLink - 00812394021321

MDLink SW 10.16
Zoll Medical Corporation
400621-046
In Commercial Distribution

400621-046

  • External defibrillator application software

AED Manager, V.2.1.1.0 Powerheart G5 - 00812394021314

Event Reporting and Administrative AED Configuration Software V.2.1.1.0 for Powerheart G5
Zoll Medical Corporation
XAEDMGR01E
In Commercial Distribution

XAEDMGR01E

  • External defibrillator application software
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