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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Precision Xtra Blood ß-Ketone Test Strips
ABBOTT DIABETES CARE INC
70745
In Commercial Distribution

  • 30093815707456 ()
  • 00093815707455 ()
  • 57599-0745-1 ()
  • 10093815707452 ()
70745

  • Multiple clinical chemistry analyte monitoring system IVD, point-of-care
  • Multiple clinical chemistry analyte monitoring system IVD, home-use
FreeStyle Unistik 2
ABBOTT DIABETES CARE INC
70428
In Commercial Distribution

  • 30093815704288 ()
  • 00093815704287 ()
  • 99073-0704-28 ()
  • 10093815704284 ()
70428

  • Glucose monitoring system IVD, home-use
Precision Xtra Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
80050
In Commercial Distribution

  • 30093815800508 ()
  • 00093815800507 ()
  • 57599-0050-1 ()
  • 10093815800504 ()
80050

  • Multiple clinical chemistry analyte monitoring system IVD, point-of-care
  • Multiple clinical chemistry analyte monitoring system IVD, home-use
FreeStyle Precision Neo Blood Glucose Monitoring System
ABBOTT DIABETES CARE INC
75175
In Commercial Distribution

  • 30093815751756 ()
  • 00093815751755 ()
  • 57599-5175-1 ()
  • 40093815751753 ()
75175

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
Optium EZ Blood Glucose Monitoring System
ABBOTT DIABETES CARE INC
71065
In Commercial Distribution

  • 30093815710654 ()
  • 00093815710653 ()
  • 57599-1065-1 ()
71065

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
Optium EZ Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
71041
In Commercial Distribution

  • 30093815710418 ()
  • 00093815710417 ()
  • 57599-1041-4 ()
  • 10093815710414 ()
71041

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
Precision Xceed Pro Blood ß-Ketone Test Strips
ABBOTT DIABETES CARE INC
70935
In Commercial Distribution

  • 35021791709350 ()
  • 00093815709350 ()
  • 57599-0935-4 ()
  • 10093815709357 ()
70935

  • Multiple clinical chemistry analyte monitoring system IVD, point-of-care
Abbott Diabetes Care USB Data Cable Software
ABBOTT DIABETES CARE INC
70845
Not in Commercial Distribution

  • 30093815000830 ()
  • 00093815000839 ()
  • 57599-0845-1 ()
70845

  • Electrical-only medical device connection cable, reusable
DUROLANE is a clear, transparent, viscous gel of highly purified, stabilized, non-animal-derived sodium hyaluronate that is biosynthesized using bacterial fermentation. NASHA® technology is used to stabilize naturally entangled hyaluronic acid (HA) chains to produce a gel. The gel is suspended in phosphate- buffered saline at a concentration of 20 mg/mL. DUROLANE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy or simple analgesics, e.g. acetaminophen.
BIOVENTUS LLC
1082020
In Commercial Distribution

  • 00816986020808 ()
  • 10816986020805 ()
  • 89130-2020-1 ()
1082020

  • Synovial fluid supplementation medium
The InPen is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments. The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data. For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use. For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use.
COMPANION MEDICAL, INC.
Novo - Pink
In Commercial Distribution

  • 62088-0000-36 ()
  • 10862088000368 ()
InPen-100NN-PK / MMT-105NNPK

  • Empty self-injector, mechanical
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