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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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Bio30+ System Physio HR - 05056336800260

Ion exchange chromatography column sold with lithium high resolution column, LED monitor, computer, autosampler and Openlab software.
BIOCHROM LIMITED
80-6000-56
In Commercial Distribution

  • 05056336800260 ()


  • Amino acid analyser IVD

Bio30+ System Physio HP - 05056336800222

Ion exchange chromatography analyzer sold with lithium high performance column, LED monitor, computer, autosampler and Openlab software.
BIOCHROM LIMITED
80-6000-53
In Commercial Distribution

  • 05056336800222 ()


  • Amino acid analyser IVD

Access Point V2C - 00850067173021

Access Point V2C is an accessory that enables wireless streaming to a computer for the Opal V2C.
APDM WEARABLE TECHNOLOGIES, INC.
AP
In Commercial Distribution

  • 00850067173021 ()


  • Kinesiology ambulatory recorder

Welch Allyn, Inc. - 00732094070729

Welch Allyn PCH-100 Holter Office Software Kit including HR-100 Holter Recorder, 7-Lead AHA Cable, Laptop Computer, Printer
WELCH ALLYN, INC.
901052
Not in Commercial Distribution

  • 00732094070729 ()
100711

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094070705

Welch Allyn PCH-200 Holter Expert Software Kit including HR-300 Holter Recorder, 7-Lead AHA Cable, Laptop Computer, Printer
WELCH ALLYN, INC.
901052
Not in Commercial Distribution

  • 00732094070705 ()
100713

  • Electrocardiograph, professional, multichannel

Access Point V2C - B628APV2C0

APDM’s Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C.
APDM, INC.
V2C
In Commercial Distribution

  • B628APV2C0 ()
APV2C

  • Kinesiology ambulatory recorder

BriefCase - 07290018052037

BriefCase is a radiological computer aided triage and notification software device. Software version 3.0.0 for CSF triage
AIDOC MEDICAL LTD
3.0.0
Not in Commercial Distribution

  • 07290018052037 ()


  • Radiology DICOM image processing application software

BriefCase - 07290018052020

BriefCase is a radiological computer aided triage and notification software device. Software version 2.0.0 for PE triage
AIDOC MEDICAL LTD
2.0.0
Not in Commercial Distribution

  • 07290018052020 ()


  • Radiology DICOM image processing application software

BriefCase - 07290018052013

BriefCase is a radiological computer aided triage and notification software device. Software version 1.1.0.0 for ICH triage.
AIDOC MEDICAL LTD
1.1.0.0
Not in Commercial Distribution

  • 07290018052013 ()


  • Radiology DICOM image processing application software

OrthAlign Plus - 00858704006558

HipAlign Instrument Tray Base
Orthalign, Inc.
403008-01
In Commercial Distribution

  • 00858704006558 ()
403008-01

  • Robotic surgical arm system
  • Orthopaedic surgical procedure kit, non-medicated, reusable
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