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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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BIS - 10884521808270

BIS (TM) Advance Monitor
Covidien LP
PMB4000
In Commercial Distribution

  • 10884521808270 ()


  • Anaesthesia depth monitor

Rapid - B761R51020

Rapid System Update
Ischemaview, Inc.
5.102
In Commercial Distribution

  • B761R51020 ()


  • Radiological PACS software

UltraviewSL - 10841522100253

MODULE BISX, 91482
SPACELABS HEALTHCARE (WASHINGTON), INC
Module: BISx
In Commercial Distribution

  • 10841522100253 ()
91482

  • Patient monitoring system module, electroencephalographic

UltraviewSL - 10841522108754

OPTION, BISX BASE MODULE, REFURB
SPACELABS HEALTHCARE (WASHINGTON), INC
91482
In Commercial Distribution

  • 10841522108754 ()
N/A

  • Patient monitoring system module, electroencephalographic

BIS Module - 00884838051515

IntelliVue Bispectral Index (BIS) Module M1034B for use with IntelliVue Patient Monitors MP40-MP90 and MX500-MX800. Bispectral Index (BIS) monitoring helps to monitor the level of consciousness of a patient under general anesthesia or sedation in the OR and ICU.
Philips Medizin Systeme Böblingen GmbH
IntelliVue BIS Module
In Commercial Distribution

  • 00884838051515 ()
866421

  • Patient monitoring system module, interfacing

Intuitive Workflow Tools - 05415334002050

accessories for image enhancement in diagnostic displays
Barco NV
2.X.X.X
In Commercial Distribution

  • 05415334002050 ()
K9308260

  • Radiology picture archiving and communication system workstation

UltraCrit Cleaning Tools - 00831829000366

UltraCrit Cleaning Tools are to be used to clean the UltraCrit and UltraCrit Plus devices.
SEPARATION TECHNOLOGY, INC.
320-113
In Commercial Distribution

  • 00831829000366 ()
  • 00831829000373 ()
320-113

  • Wash/cleaning solution IVD, manual equipment

EXINI - 07350002331033

EXINI is intended to be used by trained health-care professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear imaging (NM) and computed tomography (CT). The software provides general Picture Archiving and Communications System (PACS) tools and a clinical application for oncology including lesion marking and analysis.
Exini Diagnostics AB
3
Not in Commercial Distribution

  • 07350002331033 ()
103

  • Radiology DICOM image processing application software

Narcotrend Patient lead - 04260497025009

1-channel (3 electrodes) Component of Narcotrend-Compact M (Primary DI Number: 04260497021063)
MT MonitorTechnik GmbH & Co. KG
PKM1
In Commercial Distribution

  • 04260497025009 ()


  • Electroencephalographic monitoring system

Narcotrend Patient lead - 04260497025016

2-channel (4 electrodes) Component of Narcotrend-Compact M (Primary DI Number: 04260497021063)
MT MonitorTechnik GmbH & Co. KG
PKM4
In Commercial Distribution

  • 04260497025016 ()


  • Electroencephalographic monitoring system
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