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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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CONTOUR® NEXT - 10301937310253

Blood Glucose Test Strips - 25 Test Strips.
ASCENSIA DIABETES CARE US INC.
7310
In Commercial Distribution

  • 40301939735253 ()
  • 00301937310256 ()
  • 10301937310253 ()
  • 40301937310254 ()
  • 0193-7310-25 ()
  • 00301937310010 ()
83623099

  • Glucose monitoring system IVD, home-use

CONTOUR® NEXT - 10301937309509

Blood Glucose Test Strips - 50 Test Strips.
ASCENSIA DIABETES CARE US INC.
7309
In Commercial Distribution

  • 40301937357501 ()
  • 00301937309502 ()
  • 10301937309509 ()
  • 40301937309500 ()
  • 0193-7309-50 ()
  • 00301937309014 ()
83623080

  • Glucose monitoring system IVD, home-use

CONTOUR® NEXT - 10301937308502

Blood Glucose Test Strips - 50 Test Strips.
ASCENSIA DIABETES CARE US INC.
7308
Not in Commercial Distribution

  • 40301937308503 ()
  • 00301937308505 ()
  • 10301937308502 ()
  • 0193-7308-50 ()
  • 00301937308017 ()
83623064

  • Glucose monitoring system IVD, home-use

CONTOUR® NEXT - 10301937278706

Blood Glucose Test Strips - 35 Test Strips (per bottle) - sold in a carton of 2 bottles (70 test strips total).
ASCENSIA DIABETES CARE US INC.
7278
In Commercial Distribution

  • 40301937278707 ()
  • 00301937278709 ()
  • 10301937278706 ()
  • 00301937278013 ()
85701231

  • Glucose monitoring system IVD, home-use

CONTOUR® NEXT - 10301937277358

Blood Glucose Test strips. 35 test strips.
ASCENSIA DIABETES CARE US INC.
7277
In Commercial Distribution

  • 40301937277359 ()
  • 00301937277351 ()
  • 10301937277358 ()
  • 00301937277016 ()
85723154

  • Glucose monitoring system IVD, home-use

CONTOUR® NEXT - 00301937283352

Blood Glucose Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 10301937310253) and one 10 count bottle (Primary DI Number 10301937313100)).
ASCENSIA DIABETES CARE US INC.
7283
Not in Commercial Distribution

  • 40301937283350 ()
  • 00301937283352 ()
  • 0193-7283-35 ()
  • 00301937283017 ()
84698032

  • Glucose monitoring system IVD, home-use

CONTOUR® NEXT LINK 2.4 - 00301936262013

Wireless Blood Glucose Monitoring System. 1 Kit. For Self-testing of Diabetes. Kit Contains: CONTOUR® NEXT LINK 2.4 Blood Glucose Meter; 25 CONTOUR® NEXT Test Strips; Lancing Device; Alternative Site Endcap; 25 Lancets (provided sterile); User Guide; Quick Reference Guide; Lancing Device Insert; USB Cable; Wall Charger; Wall Charger Insert; Logbook and Carrying Case; CONTOUR® NEXT Level 2 control solution.
ASCENSIA DIABETES CARE US INC.
6262
In Commercial Distribution

  • 0193-6262-01 ()
  • 00301936262013 ()
85092979

  • Glucose monitoring system IVD, home-use

CONTOUR® NEXT LINK 2.4 - 00301936260019

Wireless Blood Glucose Monitoring System. 1 Kit. For Self-testing of Diabetes. Kit Contains: CONTOUR® NEXT LINK 2.4 Blood Glucose Meter; 25 CONTOUR® NEXT Test Strips; Lancing Device; Alternative Site Endcap; 25 Lancets (provided sterile); User Guide; Quick Reference Guide; Lancing Device Insert; USB Cable; Wall Charger; Wall Charger Insert; Logbook and Carrying Case; CONTOUR® NEXT Level 2 control solution.
ASCENSIA DIABETES CARE US INC.
6260
In Commercial Distribution

  • 00301936260019 ()
81914672

  • Glucose monitoring system IVD, home-use

Axonics - 10810005340196

Foramen Needle - Long
AXONICS MODULATION TECHNOLOGIES, INC.
9001-L
In Commercial Distribution

  • 10810005340196 ()
  • 00810005340199 ()
9001-L

  • Electrical impedance navigation spinal needle

Axonics - 10810005340189

Foramen Needle - Short
AXONICS MODULATION TECHNOLOGIES, INC.
9001-S
In Commercial Distribution

  • 10810005340189 ()
  • 00810005340182 ()
9001-S

  • Electrical impedance navigation spinal needle
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