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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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EV1000 - 00690103193473

PRESSURE CONTROLLER KIT
Edwards Lifesciences LLC
PC2K
In Commercial Distribution

  • 00690103193473 ()

  • Weight: 0.35 kg (0.77 lbs), Height: 97mm, Width: 54mm, Depth: 35mm, Cable Length: 3.5m
PC2K

  • Patient monitoring system module, blood pressure, noninvasive
  • Patient positioning sensor
  • General-purpose multi-parameter bedside monitor

EV1000 - 00690103193374

HEART REFERENCE SENSOR
Edwards Lifesciences LLC
EVHRS
In Commercial Distribution

  • 00690103193374 ()

  • Weight: 36 Gram, Cable Length: 48 Inch
EVHRS

  • Patient positioning sensor

N/A - 04961333241842

DVD-RW DRIVE, EXTERNAL USB
PENTAX OF AMERICA, INC.
1111-1977
In Commercial Distribution

  • 04961333241842 ()


  • DVD recorder

TELESIS® - 00852423006431

9250-ST Telesis® ST Software for Speech Therapy MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9250-ST
In Commercial Distribution

  • 00852423006431 ()
9250-ST

  • Biofeedback system application software

Synergy - 00852423006103

Synergy® 3-Dimensional Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9225
In Commercial Distribution

  • 00852423006103 ()
9225

  • Biofeedback system application software

Primus - 00852423006097

Primus® Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9275
In Commercial Distribution

  • 00852423006097 ()
9275

  • Biofeedback system application software

Telesis - 00852423006080

Telesis® Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9250
In Commercial Distribution

  • 00852423006080 ()
9250

  • Biofeedback system application software

QUEX-ED - 05999860882015

Biofeedback device with software
QX WORLD LTD
NA
In Commercial Distribution

  • 05999860882015 ()


  • Biofeedback system application software

DVD-RW Kit - 06944904098715

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-050177-00
In Commercial Distribution

  • 06944904098715 ()


  • DVD recorder

DVD, Field Upgrade - 06944904090733

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Z319-10
In Commercial Distribution

  • 06944904090733 ()


  • DVD recorder
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