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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
BESMED HEALTH BUSINESS CORP.
BE-92550
In Commercial Distribution

  • 04716770925509 ()


  • Analgesic transcutaneous electrical nerve stimulation system
No Description
BESMED HEALTH BUSINESS CORP.
BE-560
In Commercial Distribution

  • 04716770005607 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Humidifier Air Outlet Port Disinfection Aid
Respironics, Inc.
00
In Commercial Distribution

  • 00606959047099 ()
1127627

  • Heated respiratory humidifier
No Description
COOPERVISION, INC.
NA
In Commercial Distribution

  • 00686715000353 ()


  • Multi-purpose soft/rigid contact lens solution
No Description
COOPERVISION, INC.
NA
In Commercial Distribution

  • 00686715000339 ()


  • Multi-purpose soft/rigid contact lens solution
InSure® ONE™ Combo Pack - contains 35 Collection Kits and 1 Developer Kit
ENTERIX INC.
01
In Commercial Distribution

  • 00850093003354 ()
90035.01

  • Faecal specimen collection kit IVD, home-use
  • Faecal occult blood IVD, kit, rapid ICT, clinical
InSure® ONE™ Test Strip: Sold in Vials of 25 Strips (Part Number 12045.01) or in a sealed, bulk pouch of 200 Strips (Part Number 12041.01)
ENTERIX INC.
01
In Commercial Distribution

  • 00850093003347 ()
  • 00850093003323 ()
  • 00850093003330 ()


  • Faecal occult blood IVD, reagent
InSure® ONE™ Collection Kit: Available in 10-packs (Part Numbers 15022.01, 15027.01, 15240.01, and 90010.01), 25-packs (Part Number 90025.01) and 50-packs (15030.01, 15040.01, and 90050.01)
ENTERIX INC.
01
In Commercial Distribution

  • 30850093003317 ()
  • 00850093003316 ()
  • 20850093003310 ()
  • 10850093003313 ()


  • Faecal specimen collection kit IVD, home-use
InSure® ONE™ Sample Kit - NOT FOR SALE Contains 2 Collection Kits, 2 individually-pouched Test Strips, and 1 bottle of Run Buffer (9mL)
ENTERIX INC.
01
In Commercial Distribution

  • 00850093003309 ()
90002.01

  • Faecal occult blood IVD, kit, rapid ICT, clinical
  • Faecal specimen collection kit IVD, home-use
InSure® ONE™ Run Buffer - 1 Liter Bottle
ENTERIX INC.
01
In Commercial Distribution

  • 00850093003293 ()
14103.01

  • Faecal occult blood IVD, reagent
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