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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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Life Sensing Instruments, Inc. - 00864037000385

Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
LIFE SENSING INSTRUMENTS, INC.
TrensCenter VSP 1.000
In Commercial Distribution

  • 00864037000385 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system

Life Sensing Instruments, Inc. - 00864037000354

Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
LIFE SENSING INSTRUMENTS, INC.
TrensCenter 5.300
In Commercial Distribution

  • 00864037000354 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system

True Lok System - 18054242512752

K-WIRE, 550MM, OLIVE TL-HEX STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18054242512752 ()

  • Length: 550 Millimeter
99-54-1750

  • Orthopaedic bone wire

True Lok System - 18054242512745

K-WIRE, 450MM, NO OLIVE TL-HEX STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18054242512745 ()

  • Length: 450 Millimeter
99-54-1650

  • Orthopaedic bone wire

True Lok System - 18054242510772

5/8 RING, 220MM, TL-HEX STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18054242510772 ()

  • Internal diameter 220 mm
  • Open ring approx 5/8 circumnference
99-56-21080

  • External orthopaedic fixation system, single-use, sterile

Commwell - 07290012672026

An instrument designed to measure electrical potentials on the body surface to generate a record of the electrical currents associated with heart muscle activity [i.e., an electrocardiogram (ECG)] for the assessment of cardiac physiology. It records electrical signals from 12 leads simultaneously, thus simplifying and facilitating the interpretation of the record by enabling the comparison of 12-lead recording of the same heartbeat. It records data in electronic or printed form for Bluetooth transmission to a mobile device for later Wi-Fi or GSM transmission to a predefined web server for analysis by software or by a healthcare professional.
COMMWELL RESEARCH & DEVELOPMENT LTD.
PhysioGlove ET System
In Commercial Distribution

  • 07290012672026 ()
5-056-00

  • Multichannel electrocardiograph, noninterpretive

Commwell - 07290012672019

An instrument designed to measure electrical potentials on the body surface to generate a record of the electrical currents associated with heart muscle activity. [i.e., an electrocardiogram (ECG) for the assessment of cardiac physiology. It records electrical signals from 12 leads simultaneously, thus simplifying and facilitating the interpretation of the record by enabling the comparison of the 12-lead recording of the same heartbeat. It records data in electronic form for later analysis by software or a healthcare professional.
COMMWELL RESEARCH & DEVELOPMENT LTD.
ES-ECG System
In Commercial Distribution

  • 07290012672019 ()
5-045-00

  • Multichannel electrocardiograph, noninterpretive

Vyntus ECG - 34250892906066

No Description
Jaeger Medical GmbH
V-375610-13
In Commercial Distribution

  • 34250892906066 ()
V-375610-13

  • Electrocardiography telemetric monitoring system transmitter

Vyaire - 34250892905816

Vyntus ECG
Jaeger Medical GmbH
V-375610
In Commercial Distribution

  • 34250892905816 ()
V-375610

  • Electrocardiography telemetric monitoring system transmitter

Vyaire - 34250892905656

Carry bag Vyntus ECG
Jaeger Medical GmbH
V-841234
In Commercial Distribution

  • 34250892905656 ()
V-841234

  • Electrocardiography telemetric monitoring system transmitter
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