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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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Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2100
In Commercial Distribution

  • 06938396400439 ()


  • Portable basic diagnostic x-ray system, digital
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1100S
In Commercial Distribution

  • 06938396400422 ()


  • Portable basic diagnostic x-ray system, digital
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1100
In Commercial Distribution

  • 06938396400415 ()


  • Portable basic diagnostic x-ray system, digital
No Description
Circle Cardiovascular Imaging Inc
5.x
In Commercial Distribution

  • 00882916000011 ()


  • MRI system application software
Cardiac MR & CT imaging software application
Circle Cardiovascular Imaging Inc
5.6
In Commercial Distribution

  • 00882916000004 ()


  • MRI system application software
No Description
ICU MEDICAL, INC.
3375
In Commercial Distribution

  • 15019517053708 ()


  • Multiple vital physiological parameter monitoring system, clinical
Welch Allyn Series 300 Vital Signs Monitor with Nellcor SpO2, SureTemp Plus Thermometry, Non-invasive Blood Pressure, Pulse Rate, MAP; Supports Adult, Pediatric, and Neonatal Patients; 230 V, 50 Hz AC, IEC Plug Type-E/F
WELCH ALLYN, INC.
901057
Not in Commercial Distribution

  • 00732094105254 ()
53NT0-E4

  • Multiple vital physiological parameter monitoring system, clinical
Surveyor Central Additional Control - configured CPU English language and CD manual; 220V power; 16 monitoring slots (dual or 24 in. display required with additional CPU); No printer; Dual color LCD 24 in. monitors with high resolution and dual stand
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262933 ()
SCAC-AAB-CXDXX

  • Centralized patient monitor
Surveyor Central Additional Control - configured CPU English language and CD manual; 220V power; 24 monitoring slots (dual or 24 in. display required with additional CPU); No printer; Dual color LCD 24 in. monitors with high resolution and dual stand
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262926 ()
SCAC-AAB-DXDXX

  • Centralized patient monitor
Surveyor Central Additional Control - configured CPU Italian language and CD manual; 220V power; 4 monitoring slots (single display required with additional CPU); No printer; No display monitor
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094262919 ()
SCAC-AEB-AXXXX

  • Centralized patient monitor
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