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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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CART FOR EEG-9200 / EEG-1200
NIHON KOHDEN AMERICA, INC.
A/SONYCART-3
In Commercial Distribution

  • 00841983103766 ()
A/SONYCART-3

  • Instrument trolley
CART FOR EEG-9200 / EEG-1200
NIHON KOHDEN AMERICA, INC.
A/SONYCART
In Commercial Distribution

  • 00841983103759 ()
A/SONYCART

  • Instrument trolley
CABLE ASSEMBLY, PHOTIC, 3 FT
NIHON KOHDEN AMERICA, INC.
A/PHOTIC-3
In Commercial Distribution

  • 00841983103728 ()
A/PHOTIC-3

  • General-purpose multi-parameter bedside monitor
HL-7 NEUROWORKBENCH INTERFACE
NIHON KOHDEN AMERICA, INC.
A/NWB-HL7NIS
In Commercial Distribution

  • 00841983103711 ()
A/NWB-HL7NIS

  • Medical networking interface unit
CART FOR EEG-9200 / EEG-1200
NIHON KOHDEN AMERICA, INC.
A/NIH8000
In Commercial Distribution

  • 00841983103704 ()
A/NIH8000

  • Instrument trolley
VHRS EEG CART WITHOUT CAMERA
NIHON KOHDEN AMERICA, INC.
A/GCXCART
In Commercial Distribution

  • 00841983103698 ()
A/GCXCART

  • Instrument trolley
DC INPUT BOX FOR JE-120A AMPLIFIER
NIHON KOHDEN AMERICA, INC.
A/DCIN1200
In Commercial Distribution

  • 00841983103681 ()
A/DCIN1200

  • Electroencephalograph
EEG TREND SOFTWARE REVIEW, 10 USER
NIHON KOHDEN AMERICA, INC.
QP-160R-10
In Commercial Distribution

  • 00841983103674 ()
QP-160R-10

  • Electroencephalograph
EEG REVIEW SUITE, MULTIUSE
NIHON KOHDEN AMERICA, INC.
NK-REVSUITE-MU
In Commercial Distribution

  • 00841983103650 ()
NK-REVSUITE-MU

  • Electroencephalograph
PHOTIC ASSEMBLY WITH STIM CONTROL
NIHON KOHDEN AMERICA, INC.
NK-LS-901AJ
In Commercial Distribution

  • 00841983103643 ()
NK-LS-901AJ

  • Electroencephalograph
NEUROFAX ACQUISITION, SML FRM
NIHON KOHDEN AMERICA, INC.
EEG-1260A
In Commercial Distribution

  • 00841983104329 ()
EEG-1260A

  • Electroencephalograph
Vigilant Master Med is a component of the Vigilant Software Suite. Vigilant Master Med is part of a Dose Error Reduction System (DERS) for use with Adults, Pediatrics, and Neonates. It is intended to create, customize, and manage drug library data and device configurations to be uploaded to compatible Fresenius Kabi infusion devices which may reduce the risk of drug administration errors. It enhances safety by preventing infusion errors with the use of Dose Error Reduction System (DERS) in combination with the infusion devices.
Fresenius Kabi AG
ZK288122
In Commercial Distribution

  • 04052682044106 ()
ZK288122

  • Infusion pump medication-dosage application software
Hearing Aid Feature watchOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195950095074 ()


  • Air-conduction hearing aid, in-the-ear
Hearing Aid Feature macOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195950095067 ()


  • Air-conduction hearing aid, in-the-ear
Hearing Aid Feature AirPods Pro 2 Firmware (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149931 ()


  • Air-conduction hearing aid, in-the-ear
Hearing Aid Feature iOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149924 ()


  • Air-conduction hearing aid, in-the-ear
Orthex P&C Software v1.2
ORTHOPEDIATRICS CORP.
ORTHEXRPS
In Commercial Distribution

  • 00841132179772 ()
ORTHEXRPS

  • External orthopaedic fixation frame calculation software
Electrode Clip, Limb
NIHON KOHDEN AMERICA, INC.
NC-143E
In Commercial Distribution

  • 10841983103084 ()
  • 00841983103087 ()
NC-143E

  • Electrocardiograph, professional, multichannel
Orthex P&C Software v2
ORTHOPEDIATRICS CORP.
ORTHEXSW
In Commercial Distribution

  • 00840194428002 ()
ORTHEXSW

  • External orthopaedic fixation frame calculation software
Alaris Systems Manager v12.5.2
CAREFUSION 303, INC.
9601
In Commercial Distribution

  • 10885403519666 ()


  • Infusion pump medication-dosage application software
Calculation Services 1.X
CAREFUSION 303, INC.
1.X
In Commercial Distribution

  • 10885403510489 ()


  • Infusion pump medication-dosage application software
Infusion Adapter (v1.7.X)
CAREFUSION 303, INC.
Infusion Adapter
In Commercial Distribution

  • 10885403510472 ()


  • Infusion pump medication-dosage application software
Alaris Systems Manager v12-12.5.1
CAREFUSION 303, INC.
9601
In Commercial Distribution

  • 10885403960123 ()


  • Infusion pump medication-dosage application software
Alaris Systems Maintenance
CAREFUSION 303, INC.
8975
Not in Commercial Distribution

  • 10885403897511 ()


  • Infusion pump medication-dosage application software
Alaris Guardrails Editor 10.X
CAREFUSION 303, INC.
8961
Not in Commercial Distribution

  • 10885403896118 ()


  • Infusion pump medication-dosage application software
GTIN for 17002-02, 1/EA
ICU MEDICAL FLEET SERVICES, LLC
17002-02
In Commercial Distribution

  • 00887709127241 ()


  • Medical equipment clinical data interfacing software
GTIN for 17005-02, 1/EA
ICU MEDICAL FLEET SERVICES, LLC
17005-02
In Commercial Distribution

  • 00887709127234 ()


  • Medical equipment clinical data interfacing software
GTIN for 17003-02, 1/EA
ICU MEDICAL FLEET SERVICES, LLC
17003-02
In Commercial Distribution

  • 00887709127227 ()


  • Infusion pump medication-dosage application software
BASE
BECTON, DICKINSON AND COMPANY
516701
In Commercial Distribution

  • 60382905167012 ()
  • 50382905167015 ()
  • 00382905167010 ()
516701

  • Intravenous injection automated detection/documentation system processor/transmitter
Infusion Management System (IMS)
Fresenius Kabi AG
030-0027-05
Not in Commercial Distribution

  • 00811050530399 ()
IMS

  • Infusion pump medication-dosage application software
MY TSF HOMECARE APP ANDROID
Smith & Nephew, Inc.
71075403
In Commercial Distribution

  • 00885556808016 ()
71075403

  • Wireless patient monitor/sensor reporting software, layperson-use
No Description
ICU MEDICAL, INC.
22-0004-0206-25
In Commercial Distribution

  • 15019517225471 ()


  • Configurable electronic form web-based application software
SMART TSF.COM
Smith & Nephew, Inc.
71075401
In Commercial Distribution

  • 00885556746370 ()
71075401

  • External orthopaedic fixation frame calculation software
MY TSF HOMECARE APP iOS
Smith & Nephew, Inc.
71075402
In Commercial Distribution

  • 00885556746387 ()
71075402

  • Wireless patient monitor/sensor reporting software, layperson-use
No Description
ICU MEDICAL, INC.
22-0117-0201-25
In Commercial Distribution

  • 15019517157888 ()


  • Infusion pump medication-dosage application software
No Description
ICU MEDICAL, INC.
22-0004-0204-25
In Commercial Distribution

  • 15019517157871 ()


  • Infusion pump medication-dosage application software
SENSOR
BECTON, DICKINSON AND COMPANY
516700
In Commercial Distribution

  • 00382905167003 ()
  • 50382905167008 ()
516700

  • Intravenous line sensor, anaesthesia injection
CADDIE is cloud based artificial intelligence medical device software. CADDIE interfaces with the video feed generated by an endoscopic video processor during a colonoscopy procedure. The software is intended to be used by trained and qualified healthcare professionals as an accompaniment to video endoscopy for the purpose of drawing attention to regions with visual characteristics consistent with colonic mucosal lesions (such as polyps and adenomas). CADDIE analyses the data from the endoscopic video processor in real-time and provides information to aid the endoscopist in detecting suspected colorectal polyps, if they are in the field of view of the endoscope. The areas highlighted by CADDIE are not to be interpreted as definite polyps or adenomas. The responsibility to make a decision as to whether or not a highlighted region contains a polyp or is an adenoma lies with the user. The endoscopist is responsible for reviewing CADDIE suspected polyp areas and confirming the presence or absence of a polyp and its classification based on their own medical judgement.
ODIN MEDICAL LIMITED
v1.4.x
In Commercial Distribution

  • 15065010840024 ()


  • Endoscopic video image interpretive software
IQ HOLTER PLUG-IN SOFTWARE v10.0.6: New Software Release for Midmark Digital Holter.
MIDMARK CORPORATION
P/N 4-100-3140
In Commercial Distribution

  • 00841709118067 ()


  • Electrocardiographic long-term ambulatory recording analyser
Software, Version 11.0, CyberKnife (Operating Software group for CyberKnife Treatment Delivery System)
ACCURAY INCORPORATED
1055810
In Commercial Distribution

  • M6581055810 ()
NA

  • Linear accelerator system
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