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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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SureSigns VSi - 00884838028364

SureSigns VSi - NBP
Philips Medical Systems Hsg
863275
In Commercial Distribution

  • 00884838028364 ()
863275

  • General-purpose multi-parameter bedside monitor

TRIOS - 05902768365566

A moving cart holding a processing unit/computer (PC) that drives the handheld scanner, power supplies and a display
3shape Trios A/S
TRIOS cart
Not in Commercial Distribution

  • 05902768365566 ()


  • Dental milling system, CAD/CAM, chairside

TRIOS 3 - 05902768365504

A moving cart holding a processing unit/computer (PC) that drives the handheld scanner, power supplies and a display
3shape Trios A/S
TRIOS 3 cart
Not in Commercial Distribution

  • 05902768365504 ()


  • Dental milling system, CAD/CAM, chairside

Argus ll Psychophysical Test System - 00856264005417

Laptop computer that is connected to the Clinician Programming System. It can be used to run performance evaluation software.
Second Sight Medical Products, Inc.
014202-002-R
Not in Commercial Distribution

  • 00856264005417 ()
014202

  • Retinal prosthesis system tester/clinical evaluator

Codonics Safe Label System®(SLS) 550i Point of Care Station - 00814905020373

Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items - 143C
CODONICS INC.
550i PCS - 143C
In Commercial Distribution

  • 00814905020373 ()


  • Parenteral-nutrition management software

PD Meter - 04987669100837

The PD meter model PM-700 is a pupillary distance meter improved with a built-in computer and LCD digital display.
NIDEK CO.,LTD.
PM-700
In Commercial Distribution

  • 04987669100837 ()


  • Ophthalmodiastimeter

AVEA - 10190752159075

KIT, AVEA UPGRADE GDE & SOFTWARE
VYAIRE MEDICAL, INC.
12284-PMN
Not in Commercial Distribution

  • 10190752159075 ()
12284-PMN

  • Patient monitoring system module, pulse oximetry
  • Ventilator application software

Holter ECG and ABP System - 06944413820500

No Description
Edan Instruments, Inc.
SA-20
In Commercial Distribution

  • 06944413820500 ()


  • Electrocardiographic ambulatory recorder
  • Blood pressure ambulatory recorder

Holter ECG and ABP System - 06944413820494

No Description
Edan Instruments, Inc.
SA-19
In Commercial Distribution

  • 06944413820494 ()


  • Electrocardiographic ambulatory recorder
  • Blood pressure ambulatory recorder

Holter ECG and ABP System - 06944413820487

No Description
Edan Instruments, Inc.
SA-18
In Commercial Distribution

  • 06944413820487 ()


  • Electrocardiographic ambulatory recorder
  • Blood pressure ambulatory recorder
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