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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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OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters
LifeScan Europe GmbH
022-895
In Commercial Distribution

  • 20353885009717 ()
  • 00353885009713 ()
  • 80353885009719 ()
  • 53885-245-10 ()
022-895

  • Glucose IVD, kit, electrometry
OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters
LifeScan Europe GmbH
020-963
In Commercial Distribution

  • 20353885004187 ()
  • 00353885004183 ()
  • 80353885004189 ()
  • 30353885004184 ()
  • 53885-963-50 ()
020-963

  • Glucose IVD, kit, electrometry
OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters
LifeScan Europe GmbH
020-994
In Commercial Distribution

  • 20353885994259 ()
  • 00353885994255 ()
  • 80353885994251 ()
  • 53885-994-25 ()
020-994

  • Glucose IVD, kit, electrometry
OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. For blood glucose testing with the OneTouch Verio Family of Meters. For Kaiser Permanente Members Only
LifeScan Europe GmbH
023-061
In Commercial Distribution

  • 20353885010485 ()
  • 00353885010481 ()
  • 80353885010487 ()
  • 53885-061-50 ()
023-061

  • Glucose IVD, kit, electrometry
FreeStyle Libre 3 Sensor Kit NFRS
ABBOTT DIABETES CARE INC
72080
In Commercial Distribution

  • 30357599819003 ()
  • 00357599819002 ()
  • 57599-0819-00 ()
72080

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre 3 Sensor Kit US
ABBOTT DIABETES CARE INC
72081
In Commercial Distribution

  • 30357599818006 ()
  • 00357599818005 ()
  • 57599-0818-00 ()
72081

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Blood Glucose Test strips. Sold in a carton with a single bottle (50 test strips - RDC # 0193-7080-50), or in a carton of two bottles (100 test strips total - RDC # 0193-7090-21).
ASCENSIA DIABETES CARE US INC.
7080G
In Commercial Distribution

  • 40301939727210 ()
  • 00301937090219 ()
  • 10301937080507 ()
  • 40301939726503 ()
  • 00301937080500 ()
  • 40301937090217 ()
  • 40301937080508 ()
  • 0193-7080-50 ()
  • 00301937080012 ()
  • 40301939603040 ()
  • 40301939602043 ()
6707113

  • Glucose monitoring system IVD, home-use
reSET-O® is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008101 ()
  • 96439-0020-01 ()


  • Mental health/function therapeutic software, screen-viewed
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
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 - Blue
In Commercial Distribution

  • 62088-0000-34 ()
  • 10862088000344 ()
InPen-100NN-BL / MMT-105NNBL

  • Empty self-injector, mechanical
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