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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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Total Cholesterol Strips
KPI HEALTHCARE, INC.
CURO L5 Total Cholesterol Strips
In Commercial Distribution

  • 00860394001256 ()
  • 00860394001218 ()


  • Glucose/ketone/lipid monitoring system IVD, home-use
  • Multiple physiological parameter spot-check system analyser
  • Glucose monitoring system IVD, point-of-care
  • Glucose analyser IVD, point-of-care
  • Glucose analyser IVD, laboratory, automated/semi-automated
  • Glucose analyser IVD, laboratory, manual
  • Glucose analyser IVD, laboratory, automated
  • Glucose analyser IVD, home-use
  • Blood glucose/blood pressure monitoring system, point-of-care
  • Glucose monitoring system IVD, home-use
  • Blood glucose/blood pressure monitoring system, home-use
  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
CURO L5 Cholesterol and Glucose measuring system
KPI HEALTHCARE, INC.
CURO L5 CURO L5
In Commercial Distribution

  • 00860394001225 ()


  • Multiple physiological parameter spot-check system analyser
  • Glucose/ketone/lipid monitoring system IVD, home-use
  • Glucose monitoring system IVD, point-of-care
  • Glucose analyser IVD, point-of-care
  • Glucose analyser IVD, laboratory, automated/semi-automated
  • Glucose analyser IVD, laboratory, manual
  • Glucose analyser IVD, laboratory, automated
  • Glucose analyser IVD, home-use
  • Blood glucose/blood pressure monitoring system, point-of-care
  • Glucose monitoring system IVD, home-use
  • Blood glucose/blood pressure monitoring system, home-use
  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
LIFE SENSING INSTRUMENTS, INC.
TrensCenter 6.000
In Commercial Distribution

  • 00857769008019 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
Windows 10 Tower which is part of a multi-patient physiologic monitoring system
LIFE SENSING INSTRUMENTS, INC.
HTS820 Windows 10
In Commercial Distribution

  • 00857769008002 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
iBOTĀ® Personal Mobility Device - Wheelchair, Stair Climbing
MOBIUS MOBILITY LLC
iBOT PMD
In Commercial Distribution

  • 00857584008010 ()


  • Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
iBOTĀ® Personal Mobility Device - Wheelchair, Stair Climbing
MOBIUS MOBILITY LLC
iBOT PMD
In Commercial Distribution

  • 00857584008003 ()


  • Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
PARA Cross Pin External Fixation Frame and One Tightening Tool
A.M. SURGICAL, INC.
8800-10
In Commercial Distribution

  • 00857915007606 ()
N/A

  • External orthopaedic fixation system, single-use, sterile
Secure Screw 35mm
A.M. SURGICAL, INC.
6300-11-35
In Commercial Distribution

  • 10857915007566 ()
  • 00857915007569 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Secure Screw Starter Pack
A.M. SURGICAL, INC.
6300-K
In Commercial Distribution

  • 00857915007262 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Secure Screw 60mm
A.M. SURGICAL, INC.
6300-11-60
In Commercial Distribution

  • 10857915007238 ()
  • 00857915007231 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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