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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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SCREW, 1/4-28 LOCKING ANTERIOR LUMBAR SYSTEM NEW P/N 90-1481
Orthofix US LLC
43-6001
In Commercial Distribution

  • 18257200032594 ()


  • Spinal fixation plate, non-bioabsorbable
Blood oxygen connection /Spacelabs- Masmo / 2.2m /072+170/Nellcor/NEW Partssource
Unimed Medical Supplies, Inc.
U708N-74MR
In Commercial Distribution

  • 06945664899673 ()


  • Electrical-only medical device connection cable, reusable
Blood oxygen cable/Marquette-Masmo/2.2M/064+172/Masmo LNCS/NEW Partssource
Unimed Medical Supplies, Inc.
U708M-21R(NPS)
In Commercial Distribution

  • 06945664896283 ()


  • Electrical-only medical device connection cable, reusable
Reusable SpO2 Sensor/GE TruSignal/New lift finger clip/Adult/1.1M
Unimed Medical Supplies, Inc.
U403NC-117
In Commercial Distribution

  • 06945664888615 ()


  • Pulse oximeter probe, reusable
NEW ORLEANS STILLE NEEDLE HOLDER TC jaws 18 cm 7 in
Stille AB
104-15571
In Commercial Distribution

  • 07332339203603 ()

  • Length: 18 Centimeter
104-15571

  • Suturing needle holder, reusable
Screws (New Style to attach Scale to Reservoir on Standby Model
W. A. BAUM CO., INC.
2272NS
In Commercial Distribution

  • 00810010923486 ()
2272NS

  • Aneroid manual sphygmomanometer
PREP INF DOSE NEW OR REPLACEMENT DRESSING AND FLUSING OF LINE
STRADIS MEDICAL LLC
HCT900CHX
In Commercial Distribution

  • M752HCT900CHX0 ()
  • M752HCT900CHX5 ()


  • Vascular catheterization support/maintenance kit, non-medicated
Repetitive SpO2 Probe/Philips/Ear Clip/Adult/1.1M/087/NEW Partssource
Unimed Medical Supplies, Inc.
U903-91(NPS)
In Commercial Distribution

  • 06945664896306 ()


  • Pulse oximeter probe, reusable
Repetitive SpO2 Probe/Nellcor-OXIMAX/Ear Clip/Adult/1.1M/103X/NEW Partssource
Unimed Medical Supplies, Inc.
U903-01P(NPS)
In Commercial Distribution

  • 06945664896290 ()


  • Pulse oximeter probe, reusable
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
MDLink SW 12.0
Zoll Medical Corporation
40-00580-01
In Commercial Distribution

  • 00812394021499 ()
40-00580-01

  • External defibrillator application software
MDLink SW 10.16
Zoll Medical Corporation
400621-046
In Commercial Distribution

400621-046

  • External defibrillator application software
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
Event Reporting and Administrative AED Configuration Software V 2 0 5 0 for Powerheart G5
Cardiac Science Corporation
XAEDMGR01C
In Commercial Distribution

  • 00812394020539 ()
XAEDMGR01C

  • External defibrillator application software
MDLink SW 10.15
Cardiac Science Corporation
400621-045
In Commercial Distribution

  • 00812394020393 ()
400621-045

  • External defibrillator application software
Event Reporting and Administrative AED Configuration Software V.2.1.0.6 for Powerheart G5
Cardiac Science Corporation
XAEDMGR01D
In Commercial Distribution

  • 00812394020188 ()
XAEDMGR01D

  • External defibrillator application software
Saver EVO is a user friendly information management program to assist users to manage data from their defibrillation device. Saver EVO shall allow the user to download the data from a HeartSine device to a PC computer. Saver EVO™ data management software enables downloading, revie wing and printing ECG waveforms and event history data recorded in HeartSine samaritan PAD devices. Features of Saver EVO include:Comprehensive event documentation to facilitate physician oversight, Utstein style reporting and report export capabilities, User configuration setup and time synchronization, Simple point-and-click operation
HEARTSINE TECHNOLOGIES LTD
1.4.0
In Commercial Distribution

  • M727SAVEREVOH013 ()
PAD-ACC-03

  • External defibrillator application software
jFit Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885021 ()


  • Ultrasound imaging system application software
AI4CMR v1.0 is a cloud-hosted service used with any third-party DICOM viewer applicationwhere the DICOM viewer serves as the user interface and the interface to a PACS or scanner forAI4CMR. AI4CMR is implemented as a plug-in to the DICOM viewer by the user andautomatically processes and analyses cardiac MR images received by the DICOM viewer toquantify relevant cardiac function metrics and makes the information available to the user at theuser’s discretion Indications for use: AI4CMR software is designed to report cardiac function measurements (ventricle volumes, ejection fraction, indices etc.) from 1.5T and 3T magnetic resonance (MR) scanners. AI4CMR uses artificial intelligence to automatically segment and quantify the different cardiac measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making. The user incorporating AI4CMR into their DICOM application of choice is responsible for implementing a user interface.
AI4MEDIMAGING - MEDICAL SOLUTIONS, S.A.
v1.0
In Commercial Distribution

  • 05600250059022 ()


  • MRI system application software
No Description
RESOUNDANT, INC.
3.0DKR
In Commercial Distribution

  • 00850011790199 ()
MREPLUSV3

  • MRI system application software
No Description
RESOUNDANT, INC.
MREplus 3.0.0WIN
Not in Commercial Distribution

  • 00850011790014 ()


  • MRI system application software
No Description
RESOUNDANT, INC.
MREplus 3.0.0DKR
Not in Commercial Distribution

  • 00850011790007 ()


  • MRI system application software
Cath Connect, Sensor Enabled
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067024275 ()
H702427

  • Cardiac mapping system application software
System Installation Tool
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067023841 ()
H702371

  • Cardiac mapping system application software
Utility Upgrade Kit
ST. JUDE MEDICAL, INC.
H702323
In Commercial Distribution

  • 05415067023230 ()
H702323

  • Cardiac mapping system application software
Software Upgrade Kitv.3.0.1.1
ST. JUDE MEDICAL, INC.
H21921
In Commercial Distribution

  • 05414734219211 ()
H21921

  • Cardiac mapping system application software
No Description
ST. JUDE MEDICAL, INC.
Fusion™ Module
In Commercial Distribution

  • 05414734214841 ()
75-06066-001

  • Cardiac mapping system application software
No Description
ST. JUDE MEDICAL, INC.
Fusion™ Module
In Commercial Distribution

  • 05414734214636 ()
75-05772-001

  • Cardiac mapping system application software
No Description
Exo Imaging, Inc.
EW1001
In Commercial Distribution

  • 00850018318013 ()


  • Ultrasound imaging system application software
VistaScan™ Software 1.x.x
EMAGINE SOLUTIONS TECHNOLOGY LLC
1.x.x
In Commercial Distribution

  • 00850017464001 ()


  • Ultrasound imaging system application software
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