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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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Q-Tel RMS - 00817655021447

Software accessory cleared with Q-Tel RMS
MORTARA INSTRUMENT, INC.
11089-006-70
In Commercial Distribution

  • 00817655021447 ()


  • Electrocardiography telemetric monitoring system

Q-Tel RMS - 00817655021430

Software accessory cleared with Q-Tel RMS
MORTARA INSTRUMENT, INC.
11089-005-70
In Commercial Distribution

  • 00817655021430 ()


  • Electrocardiography telemetric monitoring system

Q-Tel RMS - 00817655020105

Software accessory cleared with Q-Tel RMS
MORTARA INSTRUMENT, INC.
11089-001-70
In Commercial Distribution

  • 00817655020105 ()


  • Electrocardiography telemetric monitoring system

VULCAN - 03596010612793

PCMCIA CARD SOFTWARE VERSION 3.71 VULC
Smith & Nephew, Inc.
72201356
In Commercial Distribution

  • 03596010612793 ()
72201356

  • Radio-frequency ablation system

Xltek - 00382830023924

Sandman Codec Software V.2.0 CD-Elite
Embla Systems Ltd
4120082
In Commercial Distribution

  • 00382830023924 ()


  • Sleep disorder interpretive software

Cytomics FC500 - 15099590572839

Cytomics FC 500 with CXP Software
Beckman Coulter, Inc.
UPS (CXP)
In Commercial Distribution

  • 15099590572839 ()
626553

  • Flow cytometry analyser IVD, semi-automated

Procleix Xpress System Software - 00866489000036

The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System (software and instrument) is intended to be used to create pools of  human plasma or serum for blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the  Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 3.0
In Commercial Distribution

  • 00866489000036 ()
740769

  • Pipetting system

VistaPoint Software User Interface - 00850490007382

User interface in the patient's room
Vital Connect, Inc.
6100-03
In Commercial Distribution

  • 00850490007382 ()
6100-03

  • Electrocardiography telemetric monitoring system

VistaPoint Software User Interface - 00850490007160

User interface in the patient's room
Vital Connect, Inc.
6100-01
In Commercial Distribution

  • 00850490007160 ()
6100-01

  • Electrocardiography telemetric monitoring system

TeleRehab Software File Manager - 00856298006244

The ScottCare VersaCare Cardiopulmonary Monitoring System is designed to allow monitoring and recording of electrocardiograph (ECG) rhythm strips and related information for patients undergoing an exercise therapy program. Patients are monitored by medical telemetry exercise monitoring equipment. This feature allows patients to comply with exercise prescriptions while exercising at a medical/rehabilitation facility near their home, or by returning to the primary medical facility to participate in an in-house cardiopulmonary rehabilitation program. VersaCare includes a Program Management module that prints a variety of reports.
SCOTTCARE CORPORATION, THE
TeleRehab Software File Manager
In Commercial Distribution

  • 00856298006244 ()
101601

  • Electrocardiography telemetric monitoring system
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