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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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BREEZE® 2 - 10301931490012

Control Solution - Low, 1 x 2.5 mL
ASCENSIA DIABETES CARE US INC.
1490A
Not in Commercial Distribution

  • 50301931490010 ()
  • 40301931490013 ()
  • 00301931490015 ()
  • 10301931490012 ()
  • 0193-1490-01 ()
81007196

  • Glucose IVD, control

BREEZE® 2 - 10301931489016

Control Solution - Normal, 1 x 2.5 mL
ASCENSIA DIABETES CARE US INC.
1489A
Not in Commercial Distribution

  • 50301931489014 ()
  • 40301931489017 ()
  • 00301931489019 ()
  • 10301931489016 ()
  • 0193-1489-01 ()
81007188

  • Glucose IVD, control

XP 2 applicator - B108215APSAPWRE1000

No Description
BTL INDUSTRIES LIMITED
215-7
In Commercial Distribution

  • B108215APSAPWRE1000 ()


  • Hyperthermia system gantry

LLD™ #2 - 00813132020774

Lead Locking Device (LLD™ #2)
Spectranetics Corporation
518-022AA
In Commercial Distribution

  • M204518022AA0 ()
  • 00813132020774 ()
518-022

  • Pacing/defibrillation lead stylet, extraction

LLD™ #2 - 00813132020767

Lead Locking Device (LLD™ #2)
Spectranetics Corporation
518-019AA
In Commercial Distribution

  • 00813132020767 ()
  • M204518019AA0 ()
  • 20813132020761 ()
518-019

  • Pacing/defibrillation lead stylet, extraction

ISE Calibrator 2 - 00811403018574

To provide calibration points for the Na+, K+, and CI- electrodes on the Tokyo Boeki Biolis 24i and Prestige 24i Systems.
Diamond Diagnostics Inc.
TB-20270478D
In Commercial Distribution

  • 00811403018574 ()


  • Multiple electrolyte IVD, calibrator

Cal 2 Solution - 00811403017478

Provide a calibration point for the pH electrode.
Diamond Diagnostics Inc.
RD-943839D
In Commercial Distribution

  • 00811403017478 ()


  • Multiple electrolyte IVD, calibrator

ELECTRO-CAP SYSTEM 2 - 00811478012866

No Description
ELECTRO-CAP INTERNATIONAL INC
SYS-2
In Commercial Distribution

  • 00811478012866 ()
SYS-2

  • Analytical scalp lead

NEURO-PULSE SYSTEM 2 - 00811478012750

No Description
ELECTRO-CAP INTERNATIONAL INC
NPMS-SYS2
In Commercial Distribution

  • 00811478012750 ()
NPMS-SYS2

  • Analytical scalp lead

Calibrator, Level 2 - 00811403011568

For the calibration of Na+, K+, Cl-, Ca++, tCO2, BUN, Glucose and Creatinine.
Diamond Diagnostics Inc.
BK-465909D
In Commercial Distribution

  • 00811403011568 ()


  • Multiple electrolyte IVD, calibrator
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