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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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Vscan - 00195278640550

Vscan Air R2 for iOS
GE Vingmed Ultrasound AS
Air R2 for iOS
In Commercial Distribution

  • 00195278640550 ()


  • Ultrasound imaging system application software

EchoPAC - 00195278504326

MD EchoPAC Plug-in v206
GE Vingmed Ultrasound AS
Plug-in v206
In Commercial Distribution

  • 00195278504326 ()


  • Ultrasound imaging system application software

EchoPAC - 00195278504302

MD EchoPAC Software Only v206
GE Vingmed Ultrasound AS
Software Only v206
In Commercial Distribution

  • 00195278504302 ()


  • Ultrasound imaging system application software

CARESCAPE ONE - 00195278288639

CARESCAPE ONE MBZ323 ATO MODEL
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
MBZ323
In Commercial Distribution

  • 00195278288639 ()
2087075-300

  • Multiple vital physiological parameter monitoring system, clinical

DaTQUANT - 00195278011343

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
2.0
In Commercial Distribution

  • 00195278011343 ()


  • SPECT system application software

CLAROX plus - 08800124900017

VX-100 is a battery-operated, portable X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The VX-100 is designed for use in general-purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. Because of its low power output, the CLAROX plus (Model VX-100) is intended for exclusive use on body extremities. The functions of the VX-100 handheld system are supported by software (firmware).
VSI Co., Ltd.
VX-100
In Commercial Distribution

  • 18800124900014 ()
  • 08800124900017 ()


  • Portable basic diagnostic x-ray system, digital

Criticare - D438506DNBUS0

Monitor with DOX SPO2, NIBP, HR with Bluetooth
CRITICARE TECHNOLOGIES, INC.
eQuality 506DNB
In Commercial Distribution

  • D438506DNBUS0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Kosmos OTS iOS - 09353278000823

Kosmos Application loaded on an iPad.
ECHONOUS, INC.
iOS 4.X
Not in Commercial Distribution

  • 09353278000823 ()


  • Ultrasound imaging system application software

Kosmos OTS iOS - 09353278000762

KOSMOS OTS iOS SOFTWARE PACKAGE [2.X]
ECHONOUS, INC.
P007944
In Commercial Distribution

  • 09353278000762 ()


  • Ultrasound imaging system application software

Kosmos OTS iOS Software Package - 09353278000717

Kosmos OTS iOS Software Package
ECHONOUS, INC.
P007639
In Commercial Distribution

  • 09353278000717 ()


  • Ultrasound imaging system application software
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