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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OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip.
LifeScan Europe GmbH
023-194
In Commercial Distribution

  • 20353885010713 ()
  • 00353885010719 ()
  • 53885-194-01 ()

  • Blood Glucose measurement Level mg/dL
  • Hematocrit 20 - 60%
  • Needle Gauge: 30 Gauge
023-194

  • Glucose analyser IVD, home-use
  • Glucose monitoring system IVD, home-use
  • Manual blood lancing device, reusable
  • Blood lancing device tip
OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing For Single Patient use only.
LifeScan Europe GmbH
022-657
In Commercial Distribution

  • 20353885008710 ()
  • 00353885008716 ()
  • 53885-657-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
022-657

  • Glucose analyser IVD, home-use
  • Glucose monitoring system IVD, home-use
  • Manual blood lancing device, reusable
  • Blood lancing device tip
24 hour maintenance kit for oral care with ReddyPort Elbow. 24 hour maintenance kit includes: 1x prep pack (yankauer), 2x suction silicone toothbrush packs with anti-plaque solution (cetylpyridinium chloride 0.05%), applicator swabs and mouth moisturizer, 4x suction swab packs with suction swab, applicator swab, antiseptic oral rinse (hydrogen peroxide 1.5%) and mouth moisturizer.
SMD Manufacturing LLC
RP-MKITQ4-1
In Commercial Distribution

  • 10850001175217 ()
  • 00850001175210 ()
  • 73573-155-14 ()


  • Oral care kit, single-use
  • Basic manual toothbrush
  • Dental tooth-cleaning solution
  • Oral care swab
FreeStyle Lancets 28 Gauge
ABBOTT DIABETES CARE INC
70469
In Commercial Distribution

  • 30699073130014 ()
  • 00699073130013 ()
  • 99073-0130-01 ()
  • 10699073130010 ()
70469

  • Blood lancing device tip
Colored lancets. Silicone-coated lancets. Use with the MICROLET Family of lancing devices.
ASCENSIA DIABETES CARE US INC.
6586 / 6586W
In Commercial Distribution

  • 40301936586124 ()
  • 00301936586218 ()
  • 40301936586216 ()
  • 0193-6586-21 ()
  • 00301936586010 ()
81264857, 81264954 (US)

  • Blood lancing device tip
Reagent Strips for Urinalysis: Ketone; Glucose
ASCENSIA DIABETES CARE US INC.
2883
In Commercial Distribution

  • 40301932883500 ()
  • 00301932883502 ()
  • 10301932883509 ()
  • 0193-2882-50 ()
  • 00301932883014 ()
7081683

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Reagent Strips for Urinalysis: Ketone; Glucose
ASCENSIA DIABETES CARE US INC.
2882
In Commercial Distribution

  • 40301932882213 ()
  • 00301932882215 ()
  • 10301932882212 ()
  • 0193-2882-21 ()
  • 00301932882017 ()
15197

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Reagent Strips for Urinalysis: Ketone
ASCENSIA DIABETES CARE US INC.
2881
In Commercial Distribution

  • 40301932881216 ()
  • 00301932881218 ()
  • 10301932881215 ()
  • 0193-2880-21 ()
  • 00301932881010 ()
5778865

  • Urine ketone IVD, kit, rapid colorimetric, clinical
Reagent Strips for Urinalysis: Ketone
ASCENSIA DIABETES CARE US INC.
2880
In Commercial Distribution

  • 40301932880509 ()
  • 00301932880501 ()
  • 10301932880508 ()
  • 0193-2880-50 ()
  • 00301932880013 ()
9549534

  • Urine ketone IVD, kit, rapid colorimetric, clinical
OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip. Not for Resale or Reimbursement
LifeScan Europe GmbH
023-932
In Commercial Distribution

  • 20353885011765 ()
  • 00353885011761 ()
  • 53885-932-02 ()

  • Blood Glucose measurement Level mg/dL
  • Hematocrit 20 - 60%
023-932

  • Glucose analyser IVD, home-use
  • Glucose IVD, kit, electrometry
  • Glucose monitoring system IVD, home-use
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