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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
O'well
OW-BL-33g-300
In Commercial Distribution

  • 00850015109003 ()


  • Blood glucose/blood pressure monitoring system, home-use
The Spectrum Solutions BioMAX Specimen Collection device consists of a plastic tube designed for the collection of human saliva samples, a funnel, a cap with a stem flare, and a fluid chamber containing Spectrum’s inactivating media. Sample collection is conducted under the supervision of a Health care provider. The user deposits their saliva into the collection tube with the aid of the attached funnel, the user removes the funnel and replaces it with the cap. Upon twisting and closing the cap, the stabilizing solution is released into the tube and mixed with the saliva.
Spectrum Solutions L.L.C.
SDNA 1000
In Commercial Distribution

  • 00850015033001 ()
  • 10850015033008 ()
2019162

  • Oral/respiratory tract specimen container IVD, additive/medium
No Description
MEDIBIO USA LLC
TD-4277
In Commercial Distribution

  • 00850014981051 ()


  • Glucose IVD, kit, electrometry
No Description
MEDIBIO USA LLC
TD-2555
In Commercial Distribution

  • 00850014981037 ()


  • Stand-on floor scale, electronic
No Description
MEDIBIO USA LLC
TD-8255
In Commercial Distribution

  • 00850014981020 ()


  • Pulse oximeter
No Description
MEDIBIO USA LLC
TD-4277
In Commercial Distribution

  • 00850014981013 ()


  • Glucose monitoring system IVD, home-use
No Description
MEDIBIO USA LLC
TD-3140
In Commercial Distribution

  • 00850014981006 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
AQUA CLEANSE COLON IRRIGATION DEVICE
QUALITY MEDICAL SUPPLY, INC.
01
In Commercial Distribution

  • 00850014947163 ()


  • Colonic lavage unit
42" CUFFED, HYDROCARE DISPOSABLE KIT
QUALITY MEDICAL SUPPLY, INC.
01
In Commercial Distribution

  • 00850014947156 ()


  • Colonic lavage kit, non-surgical
42" SMOOTH-INTERIOR, HYDROCARE DISPOSABLE KIT
QUALITY MEDICAL SUPPLY, INC.
01
In Commercial Distribution

  • 00850014947149 ()


  • Colonic lavage kit, non-surgical
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