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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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VGPMT0501 HIGH PRESSURE TUBING (30cm)
VALFLUX GROUP, LLC
VGPMT0501
In Commercial Distribution

  • 00850004162064 ()
VGPMT0501

  • Arterial blood pressure catheter
Bigfoot Alcohol Prep Pads, 70% v/v Isopropyl Alcohol, 100CT
Bigfoot Biomedical, Inc.
FG-300145
In Commercial Distribution

  • 00850003506081 ()
FG-300145

  • Skin-cleaning wipe, sterile
Aveta Waste Management Accessory for use with Aveta System
MEDITRINA, INC.
205-2003
In Commercial Distribution

  • 00850006759453 ()
  • 00850006759446 ()
205-2003

  • Surgical tissue/fluid collection bag, non-sterile
Aveta Waste Management Accessory (with cap) for use with Aveta System
MEDITRINA, INC.
205-2001
In Commercial Distribution

  • 00850006759392 ()
  • 00850006759385 ()
205-2001

  • Surgical tissue/fluid collection bag, non-sterile
Aveta Waste Bag (with cap), for use with Aveta System
MEDITRINA, INC.
205-2000
In Commercial Distribution

  • 00850006759378 ()
  • 00850006759361 ()
205-2000

  • Surgical tissue/fluid collection bag, non-sterile
Aveta Waste Management Accessory for use with Aveta System
MEDITRINA, INC.
205-224
In Commercial Distribution

  • 00850006759156 ()
  • 00850006759149 ()
205-224

  • Surgical tissue/fluid collection bag, non-sterile
Aveta Waste Bag. 6L, for use with Aveta System
MEDITRINA, INC.
205-105
In Commercial Distribution

  • 00850006759217 ()
  • 00850006759118 ()
205-105

  • Surgical tissue/fluid collection bag, non-sterile
CURO L5 Glucose Strip
KPI HEALTHCARE, INC.
Curo L5
In Commercial Distribution

  • 00850006113064 ()
  • 00850006113057 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
  • Blood glucose/blood pressure monitoring system, home-use
  • Glucose monitoring system IVD, home-use
  • Blood glucose/blood pressure monitoring system, point-of-care
  • Glucose analyser IVD, home-use
  • Glucose analyser IVD, laboratory, automated
  • Glucose analyser IVD, laboratory, manual
  • Glucose analyser IVD, laboratory, automated/semi-automated
  • Glucose analyser IVD, point-of-care
  • Glucose monitoring system IVD, point-of-care
  • Glucose/ketone/lipid monitoring system IVD, home-use
  • Multiple physiological parameter spot-check system analyser
CURO A1c Daily Check Cartridge
KPI HEALTHCARE, INC.
CURO A1c
In Commercial Distribution

  • 00850006113040 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
  • Blood glucose/blood pressure monitoring system, home-use
  • Glucose monitoring system IVD, home-use
  • Blood glucose/blood pressure monitoring system, point-of-care
  • Glucose analyser IVD, home-use
  • Glucose analyser IVD, laboratory, automated
  • Glucose analyser IVD, laboratory, manual
  • Glucose analyser IVD, laboratory, automated/semi-automated
  • Glucose analyser IVD, point-of-care
  • Glucose monitoring system IVD, point-of-care
Curo A1c Test Cartridge
KPI HEALTHCARE, INC.
CURO A1c
In Commercial Distribution

  • 00850006113033 ()
  • 00850006113002 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
  • Blood glucose/blood pressure monitoring system, home-use
  • Glucose monitoring system IVD, home-use
  • Blood glucose/blood pressure monitoring system, point-of-care
  • Glucose analyser IVD, home-use
  • Glucose analyser IVD, laboratory, automated
  • Glucose analyser IVD, laboratory, manual
  • Glucose analyser IVD, laboratory, automated/semi-automated
  • Glucose analyser IVD, point-of-care
  • Glucose monitoring system IVD, point-of-care
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