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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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PharmGuard - 15019517088632

No Description
ICU MEDICAL, INC.
22-4095-0204-25
In Commercial Distribution

  • 15019517088632 ()


  • Infusion pump medication-dosage application software

Q21 - 00860410000379

The Q21 is a 19 channel EEG amplifier with a low noise floor of 0.25 microvolts peak to peak from 0.1 to 10.0Hz, meaning that you can record brain wave data without worrying about noise contamination. On top of our low-noise design, the Q21 is a non-multiplexed, multi-channel readout amp, minimizing slew for the most accurate whole brain imaging, and giving you the exact readout of your EEG recordings, with no loss of data or smoothing.
NEUROFIELD, INC.
169
In Commercial Distribution

  • 00860410000379 ()


  • Multiple physiological signal amplifier

Arcad Aligners - 00860011071921

Top and Bottom Aligners
ARCADLAB
Clear Orthodontic Aligners
In Commercial Distribution

  • 00860011071921 ()


  • Orthodontic aligner auxiliary attachment kit

Orthex - 00841132179772

Orthex P&C Software v1.2
ORTHOPEDIATRICS CORP.
ORTHEXRPS
In Commercial Distribution

  • 00841132179772 ()
ORTHEXRPS

  • External orthopaedic fixation frame calculation software

Orthex External Fixation System - 00840194428002

Orthex P&C Software v2
ORTHOPEDIATRICS CORP.
ORTHEXSW
In Commercial Distribution

  • 00840194428002 ()
ORTHEXSW

  • External orthopaedic fixation frame calculation software

Alaris - 10885403960123

Alaris Systems Manager v12-12.5.1
CAREFUSION 303, INC.
9601
In Commercial Distribution

  • 10885403960123 ()


  • Infusion pump medication-dosage application software

Alaris - 10885403897511

Alaris Systems Maintenance
CAREFUSION 303, INC.
8975
Not in Commercial Distribution

  • 10885403897511 ()


  • Infusion pump medication-dosage application software

Alaris - 10885403896118

Alaris Guardrails Editor 10.X
CAREFUSION 303, INC.
8961
Not in Commercial Distribution

  • 10885403896118 ()


  • Infusion pump medication-dosage application software

Alaris - 10885403519666

Alaris Systems Manager v12.5.2
CAREFUSION 303, INC.
9601
In Commercial Distribution

  • 10885403519666 ()


  • Infusion pump medication-dosage application software

Alaris - 10885403510489

Calculation Services 1.X
CAREFUSION 303, INC.
1.X
In Commercial Distribution

  • 10885403510489 ()


  • Infusion pump medication-dosage application software
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