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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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Sherlock 3CG+, BD SiteRite 9 Ultrasound System - 00801741219214

SiteRite 9 Sherlock Software
Bard Access Systems, Inc.
Sherlockv3.3.0
In Commercial Distribution

  • 00801741219214 ()
Sherlockv3.3.0

  • General-purpose ultrasound imaging system
  • Central venous catheter navigation system, electrocardiographic/magnetic

ManoView - 07290101369578

ManoView ESO Software v3.3
Given Imaging, Inc.
FGS-0628
In Commercial Distribution

  • 07290101369578 ()


  • Manometric gastrointestinal motility analysis system

PillCam - 07290101366751

PillCam Software v9.0, USA
Given Imaging, Inc.
FGS-0612
In Commercial Distribution

  • 07290101366751 ()


  • Video capsule endoscopy system application software

Manoscan - 07290101366102

CLT v3.0 software upgrade
Given Imaging, Inc.
FGS-0580
In Commercial Distribution

  • 07290101366102 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101365945

v3.0 software kit upgrade
Given Imaging, Inc.
FGS-0573
In Commercial Distribution

  • 07290101365945 ()


  • Manometric gastrointestinal motility analysis system

ManoView - 07290101365938

CLT v3.0 software kit
Given Imaging, Inc.
FGS-0572
In Commercial Distribution

  • 07290101365938 ()


  • Manometric gastrointestinal motility analysis system

ManoView - 07290101365785

AR v3.0 Software kit
Given Imaging, Inc.
FGS-8030
In Commercial Distribution

  • 07290101365785 ()


  • Manometric gastrointestinal motility analysis system

OrthoNext™ Platform System Software - 18059015375831

ORTHONEXT SOFTWARE VERSION 2.1
ORTHOFIX SRL
2.1
In Commercial Distribution

  • 18059015375831 ()
ORTHONEXTSW2.1

  • Radiological PACS software

DOSE IQ SAFETY SOFTWARE - 20085412676610

Infusion Safety Management Software
BAXTER HEALTHCARE CORPORATION
1.9
In Commercial Distribution

  • 20085412676610 ()
DOSEIQW0001

  • Infusion pump medication-dosage application software

LifeShield Infusion Safety Software Suite - LifeShield DLM - 00887709122802

Infusion Safety Management Software
ICU MEDICAL, INC.
2.1
In Commercial Distribution

  • 00887709122802 ()
17003-01

  • Infusion pump medication-dosage application software

DianaTM Compounding Workflow System - 00887709126770

Diana Web Server Software
ICU MEDICAL, INC.
DS2800-04-01
In Commercial Distribution

  • 00887709126770 ()
DS2800-04-01

  • Pharmaceutical fluid-dispensing system

DianaTM Compounding Workflow System - 00887709126749

Diana Workflow Management Software
ICU MEDICAL, INC.
DS2110-04-01
In Commercial Distribution

  • 00887709126749 ()
DS2110-04-01

  • Pharmaceutical fluid-dispensing system

LifeShield Infusion Safety Software Suite - LifeShield CDR - 00887709122819

Infusion Safety Management Software
ICU MEDICAL, INC.
2.1
In Commercial Distribution

  • 00887709122819 ()
17005-01

  • Medical equipment clinical data interfacing software

HeartSee Cardiac PET Processing Software - 30815112020584

Cardiac PET Processing Software
Bracco Diagnostics Inc.
1.00
In Commercial Distribution

  • 30815112020584 ()
001771

  • Image segmentation application software

ARROW - 00801902084859

AutoCAT2 Modem Connection Software
TELEFLEX INCORPORATED
IPN000284
In Commercial Distribution

  • 00801902084859 ()
IAM-2004

  • Intra-aortic balloon pump

uWS - 06971576834020

CT Image Post-Processing Software
Shanghai United Imaging Healthcare Co., Ltd.
uWS-CT
In Commercial Distribution

  • 06971576834020 ()


  • Radiology DICOM image processing application software

uWS - 06971576834013

MR Image Post-Processing Software
Shanghai United Imaging Healthcare Co., Ltd.
uWS-MR
In Commercial Distribution

  • 06971576834013 ()


  • MRI system application software

Ascom - 17350088671396

TELLIGENCE BRIDGE SOFTWARE V7.0
Ascom (Sweden) AB
NGTELL70-S
In Commercial Distribution

  • 17350088671396 ()


  • Nurse call system

Ascom - 17350088671372

TELLIGENCE BRIDGE SOFTWARE V6.4
Ascom (Sweden) AB
NGTELL64-S
In Commercial Distribution

  • 17350088671372 ()


  • Nurse call system

Ascom - 17350088671297

TELLIGENCE BRIDGE SOFTWARE V6.3
Ascom (Sweden) AB
NGTELL63-S
In Commercial Distribution

  • 17350088671297 ()


  • Nurse call system

Ascom - 17350088671266

TELLIGENCE BRIDGE SOFTWARE V5.2
Ascom (Sweden) AB
NGTELL52-S
In Commercial Distribution

  • 17350088671266 ()


  • Nurse call system

Ascom - 17350088671259

TELLIGENCE BRIDGE SOFTWARE V6.2
Ascom (Sweden) AB
NGTELL62-S
In Commercial Distribution

  • 17350088671259 ()


  • Nurse call system

ASCOM - 17350088671167

TELLIGENCE BRIDGE SOFTWARE V6.1
Ascom (Sweden) AB
NGTELL61-S
In Commercial Distribution

  • 17350088671167 ()


  • Nurse call system

Ascom - 17350088670887

TELLIGENCE BRIDGE SOFTWARE V5.3
Ascom (Sweden) AB
NGTELL53-S
In Commercial Distribution

  • 17350088670887 ()


  • Nurse call system

Ascom - 17350088670870

TELLIGENCE BRIDGE SOFTWARE V6.9
Ascom (Sweden) AB
NGTELL69-S
In Commercial Distribution

  • 17350088670870 ()


  • Nurse call system

Ascom - 17350088670825

TELLIGENCE BRIDGE SOFTWARE V6.10
Ascom (Sweden) AB
NGTELL610-S
In Commercial Distribution

  • 17350088670825 ()


  • Nurse call system

Ascom - 17350088670740

TELLIGENCE BRIDGE SOFTWARE V6.8
Ascom (Sweden) AB
NGTELL68-S
In Commercial Distribution

  • 17350088670740 ()


  • Nurse call system

Ascom - 17350088670726

TELLIGENCE BRIDGE SOFTWARE V6.6
Ascom (Sweden) AB
NGTELL66-S
In Commercial Distribution

  • 17350088670726 ()


  • Nurse call system

Ascom - 17350088670719

TELLIGENCE BRIDGE SOFTWARE V6.5
Ascom (Sweden) AB
NGTELL65-S
In Commercial Distribution

  • 17350088670719 ()


  • Nurse call system

Ascom - 17350088670610

TELLIGENCE BRIDGE SOFTWARE V5.1
Ascom (Sweden) AB
NGTELL51-S
Not in Commercial Distribution

  • 17350088670610 ()


  • Nurse call system
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