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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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RHYTHMIA HDx™ - 08714729938538

ECG IN Cable (Limb and Chest)
BOSTON SCIENTIFIC CORPORATION
M004RA5110I0
In Commercial Distribution

  • 08714729938538 ()


  • Electrocardiographic lead set, reusable

RHYTHMIA HDx™ - 08714729938521

ECG IN Cable (Limb and Chest)
BOSTON SCIENTIFIC CORPORATION
M004RA5110A0
In Commercial Distribution

  • 08714729938521 ()


  • Electrocardiographic lead set, reusable

RHYTHMIA HDx™ - 08714729938514

ECG IN Cable (Trunk)
BOSTON SCIENTIFIC CORPORATION
M004RA5010I0
In Commercial Distribution

  • 08714729938514 ()


  • Electrocardiographic lead set, reusable

RHYTHMIA HDx™ - 08714729938507

ECG IN Cable (Trunk)
BOSTON SCIENTIFIC CORPORATION
M004RA5010A0
In Commercial Distribution

  • 08714729938507 ()


  • Electrocardiographic lead set, reusable

Fenwal DXT Relay - 00811137013050

Fenwal DXT Relay is a Microsoft Windows-based software application intended to be used by trained blood center professionals to receive and transmit data between blood bank instruments (apheresis and nonapheresis) and computer systems. The data may also be stored in and accessed from Fenwal DXT Relay’s database
FENWAL, INC.
2.2
In Commercial Distribution

  • 00811137013050 ()
5S9804

  • Blood bank information system application software
  • Medical equipment clinical data interfacing software

EV1000 - 00690103190151

EV1000 VOLUMEVIEW CABLE
Edwards Lifesciences LLC
EVVVTC1
In Commercial Distribution

  • 00690103190151 ()

  • Length: 93 Inch
EVVVTC1

  • Electrical-only medical device connection cable, reusable
  • Patient positioning sensor

Welch Allyn, Inc. - 00732094336832

TRIAL RETINAVUE700 IMAGER SET US PLUG
WELCH ALLYN, INC.
901124
In Commercial Distribution

  • 00732094336832 ()
RV700-BT

  • Ophthalmic fundus camera

Welch Allyn, Inc. - 00732094323948

RV700 IMAGER SET TRADE-UP DISTRIBUTOR
WELCH ALLYN, INC.
901124
Not in Commercial Distribution

  • 00732094323948 ()
RV700TUD-B

  • Ophthalmic fundus camera

Welch Allyn, Inc. - 00732094299939

RETINAVUE700 IMAGER US
WELCH ALLYN, INC.
901124
Not in Commercial Distribution

  • 00732094299939 ()
  • 00732094323214 ()
RV700 B

  • Ophthalmic fundus camera

INTELLISPACE™ COGNITION - 00884838104587

Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the cognition of individuals. It is a cloud-based Software as a Service consisting of both a patient interface on a tablet and a clinician interface that can be used on any PC or tablet. The patient uses a digital pencil on the tablet to complete a cognitive assessment. The application immediately scores the tests, compares to norms and displays the results in terms of cognitive domains as part of a comprehensive report.
Philips Electronics Nederland B.V.
5.0.x.x
Not in Commercial Distribution

  • 00884838104587 ()
821401000000

  • Cognitive assessment software
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