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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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No Description
TENS PLUS INDUSTRIAL COMPANY
Cup.Pump.5
In Commercial Distribution

  • 14897076721396 ()


  • Cupping therapy device
This oxygen concentrator is intended for using as an oxygen supplement device in the professional healthcare facility andhome healthcare environment. It provides high concentration of oxygen to persons requiring oxygen therapy. This device is to beused as an oxygen supplement and is NOT considered life-supporting or life-sustaining.
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
Voxi 5
In Commercial Distribution

  • 06933257935419 ()


  • Stationary oxygen concentrator
MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain, MRCAT Head &Neck)
Philips Medical Systems Nederland B.V.
RTgo 5
In Commercial Distribution

  • 00884838122123 ()
781439

  • MRI system application software
No Description
Circle Cardiovascular Imaging Inc
5.x
In Commercial Distribution

  • 00882916000011 ()


  • MRI system application software
Scar and Laser Gel
IMPLANTECH ASSOCIATES, INC.
5 gram
In Commercial Distribution

  • M724CSG051 ()
  • M724CSG0512PK2 ()
CSG-05

  • Scar-management dressing, reusable
Xoran Workstation is an image processing and viewing software for use with compatible radiographic data. The workstation software provides tools for image processing, viewing, interpretation, annotation, clinical review, analysis, distribution, archival, printing, and administrative reporting by healthcare professionals.
XORAN TECHNOLOGIES LLC
v.5
In Commercial Distribution

  • 00860008443717 ()


  • Diagnostic x-ray digital imaging system workstation application software
No Description
Sysmex America, Inc.
5.X
In Commercial Distribution

  • 00664369000752 ()


  • Clinical laboratory information system
One time use sterile emergency airway kit that contains (1) Disposable Scalpel #10 blade, (1) Endotracheal Tube, 6.0 mm cuffed, (1) 10 cc syringe, (1) 35 cm Bougie and Twill Tape.
H&H MEDICAL CORPORATION
Version 5
In Commercial Distribution

  • 00857048006477 ()

  • Length: 9.25 Inch
  • Width: 4.0 Inch
  • Height: 1.75 Inch
HHRCK01

  • Cricothyrotomy kit, single-use
One time use sterile emergency airway kit that contains (1) Disposable Scalpel #10 blade, (1) Endotracheal Tube, 6.0 mm cuffed, (1) Curved Crile Hemostat, (1) News Tracheal Hook, (1) 10 cc syringe, (1) 35 cm Bougie and Twill Tape.
H&H MEDICAL CORPORATION
Version 5
In Commercial Distribution

  • 00857048006002 ()

  • Height: 1.75 Inch
  • Width: 4.0 Inch
  • Length: 9.25 Inch
HHECT01

  • Cricothyrotomy kit, single-use
The Glooko Mobile application for iOS and Android displays retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)
GLOOKO, INC.
5.xx
In Commercial Distribution

  • 00855093008033 ()


  • Clinical management support software
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