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 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 Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing For Single Patient use only.
LifeScan Europe GmbH
022-658
In Commercial Distribution

  • 20353885008727 ()
  • 00353885008723 ()
  • 53885-658-01 ()

  • Needle Gauge: 30 Gauge
  • Blood Glucose measurement Level mg/dL
  • Hematocrit 20 - 60%
022-658

  • Glucose monitoring system IVD, home-use
  • Glucose analyser IVD, home-use
  • Glucose IVD, kit, electrometry
  • Blood lancing device tip
  • Manual blood lancing device, reusable
  • Glucose IVD, control
OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip. Not for Resale or Reimbursement
LifeScan Europe GmbH
023-270
In Commercial Distribution

  • 20353885010973 ()
  • 00353885010979 ()
  • 53885-271-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
023-270

  • Glucose analyser IVD, home-use
  • Glucose monitoring system IVD, home-use
  • Glucose IVD, kit, electrometry
  • Manual blood lancing device, reusable
  • Blood lancing device tip
OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-913
In Commercial Distribution

  • 20353885002688 ()
  • 00353885002684 ()
  • 53885-913-01 ()

  • Needle Gauge: 30 Gauge
  • Blood Glucose measurement Level mg/dL
  • Hematocrit 30 - 55%
021-913

  • Glucose analyser IVD, home-use
  • Manual blood lancing device, reusable
  • Glucose IVD, kit, electrometry
  • Blood lancing device tip
OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-422
In Commercial Distribution

  • 20353885001315 ()
  • 00353885001311 ()
  • 53885-422-01 ()

  • Needle Gauge: 30 Gauge
  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
021-422

  • Glucose analyser IVD, home-use
  • Glucose IVD, kit, electrometry
  • Blood lancing device tip
  • Manual blood lancing device, reusable
OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-211
In Commercial Distribution

  • 20353885000516 ()
  • 00353885000512 ()
  • 53885-211-01 ()

  • Needle Gauge: 30 Gauge
  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
021-211

  • Glucose analyser IVD, home-use
  • Glucose IVD, kit, electrometry
  • Blood lancing device tip
  • Manual blood lancing device, reusable
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 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 Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-208
In Commercial Distribution

  • 20353885000486 ()
  • 00353885000482 ()
  • 53885-208-01 ()

  • Needle Gauge: 30 Gauge
  • Blood Glucose measurement Level mg/dL
  • Hematocrit 30 - 55%
021-208

  • Glucose analyser IVD, home-use
  • Manual blood lancing device, reusable
  • Blood lancing device tip
Sterile Surgical Lubricant, Packet
HR PHARMACEUTICALS INC.
281020557
In Commercial Distribution

  • 30851809002471 ()
  • 00851809002470 ()
  • 10851809002477 ()
  • 20851809002474 ()
  • 00281020557 ()

  • Weight: 31 Gram
281020557

  • General-body orifice lubricant
  • Multi-purpose surgical instrument lubricant
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