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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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MICROLET® - 00301936586218

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

Prodigy No Coding Blood Glucose Test Strips - 00384840750500

Prodigy No Coding Blood Glucose Test Strips (100 ct) with FREE AutoCode meter.
Prodigy Diabetes Care, LLC
75050
In Commercial Distribution

  • 00384841732000 ()
  • 08484-0750-50 ()
  • 00384840750500 ()
  • 30384840750501 ()
075050

  • Glucose monitoring system IVD, home-use

Prodigy No Coding Blood Glucose Test Strips - 00384840105003

Prodigy No Coding Blood Glucose Test Strips (100 ct) with FREE AutoCode meter.for eCommerce
Prodigy Diabetes Care, LLC
010500
In Commercial Distribution

  • 00384840105003 ()
  • 00384841104005 ()
  • 00384844105009 ()
  • 3 84840 10500 ()
010500

  • Glucose monitoring system IVD, home-use

ReddyPort - 00850001175210

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

OneTouch Ultra2 - 00353885000277

OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-098
In Commercial Distribution

  • 20353885000271 ()
  • 00353885000277 ()
  • 53885-448-01 ()

  • Needle Gauge: 30 Gauge
  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
021-098

  • Blood lancing device tip
  • Manual blood lancing device, reusable
  • Glucose monitoring system IVD, home-use

OneTouch Ultramini - 00353885001281

OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-419
In Commercial Distribution

  • 20353885001285 ()
  • 00353885001281 ()
  • 53885-419-01 ()

  • Needle Gauge: 30 Gauge
  • Blood Glucose measurement Level mg/dL
  • Hematocrit 30 - 55%
021-419

  • Glucose analyser IVD, home-use
  • Blood lancing device tip
  • Manual blood lancing device, reusable

OneTouch Ultramini - 00353885002677

OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-911
In Commercial Distribution

  • 20353885002671 ()
  • 00353885002677 ()
  • 53885-911-01 ()

  • Needle Gauge: 30 Gauge
  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
021-911

  • Glucose analyser IVD, home-use
  • Blood lancing device tip
  • Manual blood lancing device, reusable

OneTouch Verio - 00353885009768

OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTouch Verio Family of Meters
LifeScan Europe GmbH
022-899
In Commercial Distribution

  • 20353885009762 ()
  • 00353885009768 ()
  • 80353885009764 ()
  • 53885-271-50 ()
022-899

  • Glucose IVD, kit, electrometry

OneTouch Verio - 00353885009751

OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTouch Verio Family of Meters
LifeScan Europe GmbH
022-898
In Commercial Distribution

  • 20353885009755 ()
  • 00353885009751 ()
  • 80353885009757 ()
  • 53885-272-10 ()
022-898

  • Glucose IVD, kit, electrometry

OneTouch Verio - 00353885007733

OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTouch Verio Family of Meters
LifeScan Europe GmbH
022-270
In Commercial Distribution

  • 20353885007737 ()
  • 00353885007733 ()
  • 80353885007739 ()
  • 53885-270-25 ()
022-270

  • Glucose IVD, kit, electrometry
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