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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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UltraviewSL - 10841522100253

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

  • 10841522100253 ()
91482

  • Patient monitoring system module, electroencephalographic

Rapid - B761R51020

Rapid System Update
Ischemaview, Inc.
5.102
In Commercial Distribution

  • B761R51020 ()


  • Radiological PACS software

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

BIS - 10884521808317

BIS (TM) Advance Monitor
Covidien LP
PMB4000ACBL
In Commercial Distribution

  • 10884521808317 ()


  • Analytical scalp lead

BIS - 10884521808300

BIS (TM) Advance Docking Station
Covidien LP
PMB4000DOC
In Commercial Distribution

  • 10884521808300 ()


  • Anaesthesia depth monitor

BIS - 10884521808270

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

  • 10884521808270 ()


  • Anaesthesia depth monitor

Xoran Workstation - 00860008443717

Xoran Workstation is an image processing and viewing software for use with compatible radiographic data. The workstation software provides tools for image processing, viewing, interpretation, annotation, clinical review, analysis, distribution, archival, printing, and administrative reporting by healthcare professionals.
XORAN TECHNOLOGIES LLC
v.5
In Commercial Distribution

  • 00860008443717 ()


  • Diagnostic x-ray digital imaging system workstation application software

Xoran Workstation - 00860290000391

Xoran Workstation is an image processing and viewing software for use with compatible radiographic data. The workstation software provides tools for image processing, viewing, interpretation, annotation, clinical review, analysis, distribution, archival, printing, and administrative reporting by healthcare professionals.
XORAN TECHNOLOGIES LLC
v5.15.5
In Commercial Distribution

  • 00860290000391 ()


  • Diagnostic x-ray digital imaging system workstation application software

Halyard - 20680651474487

Assisted Care 24-Hour Oral Care Kit with Suction Tools (Mexico)
Avanos Medical, Inc.
47448
In Commercial Distribution

  • 30680651474484 ()
  • 20680651474487 ()
970600

  • Oral care kit, single-use

NovoTAL Software for Array Mapping - 07290107981729

No Description
Novocure GmbH
NovoTAL Software
In Commercial Distribution

  • 07290107981729 ()
90094

  • Alternating electric field antimitotic cancer treatment system generator
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