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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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The Revogene Check is a single-use, qualitative test utilizing automated real-time Polymerase Chain Reaction (PCR) to confirm that the optical and thermal parameters of the Revogene Instrument are within specifications. It is intended for use by qualified laboratory personnel who have been trained and are proficient in performing testing on the Revogene instrument or by Meridian Bioscience service personnel.
MERIDIAN BIOSCIENCE, INC.
610220
In Commercial Distribution

  • 00840733103285 ()
610220

  • Thermal cycler nucleic acid instrument calibrator/control kit IVD
Xpert Check; 5 each per kit
CEPHEID
XPERTCHECK-US-5
In Commercial Distribution

  • 07332940001872 ()
XPERTCHECK-US-5

  • Thermal cycler nucleic acid instrument calibrator/control kit IVD
Abbott m2000rt Optical Calibration Kit
ABBOTT MOLECULAR INC.
04J71-93
In Commercial Distribution

  • 00884999006577 ()
04J71-93

  • Thermal cycler nucleic acid instrument calibrator/control kit IVD
TIDIShield Slush/Warming Machine Covers Clear Polyethylene 54in x 54in 250 per Case
TIDI PRODUCTS, LLC
CFI-704 N/S
Not in Commercial Distribution

  • 00618125140596 ()


  • Medical equipment/instrument drape, single-use
Bi-PAP Connector 22m-15F/22m with Exhaust Valve & Bacterial / Viral Filters (Patient & Machine End)
FLEXICARE MEDICAL LIMITED
010-708U
In Commercial Distribution

  • 05055931103868 ()


  • Non-rebreathing valve, single-use
Sunset Suction Machine Only - with AC Power Only, Detachable Power Cord & Carry Case
SUNSET HEALTHCARE SOLUTIONS, INC.
SU100AC-A
In Commercial Distribution

  • 00848530096199 ()


  • Emergency airway clearance suction pump, electric
Ecg machine lead wire /MQ type/ten lead/clamp type /AHA/ 1.2m + 0.8m
Unimed Medical Supplies, Inc.
AE3008
In Commercial Distribution

  • 06945664891899 ()


  • Electrocardiographic lead set, reusable
No Description
EMD Technologies
EPS SYS AG
In Commercial Distribution

  • 00055846500085 ()


  • Diagnostic x-ray system generator, stationary
No Description
Sonova AG
incl. EU EPS
In Commercial Distribution

  • 07613389759020 ()
075-5891-12

  • Noninvasive device battery charger
No Description
Sonova AG
incl. US EPS
In Commercial Distribution

  • 07613389759013 ()
075-5891-11

  • Noninvasive device battery charger
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