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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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QUALICHECK 5+, LEVEL 4 - 05700699440204

S7760 QUALICHECK5+, level 4 GREEN box of 30 ampoules. For ABL5/5XX, ABL7XX, EML10X
Radiometer Medical ApS
944-020
In Commercial Distribution

  • 55700699440209 ()
  • 05700699440204 ()
944-020

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

QUALICHECK 5+, LEVEL 3 - 05700699440198

S7750 QUALICHECK5+, level 3 BLUE box of 30 ampoules. For ABL5/5XX, ABL7XX, EML10X
Radiometer Medical ApS
944-019
In Commercial Distribution

  • 55700699440193 ()
  • 05700699440198 ()
944-019

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

QUALICHECK 5+, LEVEL 2 - 05700699440181

S7740 QUALICHECK5+, level 2 YELLOW box of 30 ampoules. For ABL5/5XX, ABL7XX, EML10X
Radiometer Medical ApS
944-018
In Commercial Distribution

  • 55700699440186 ()
  • 05700699440181 ()
944-018

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

QUALICHECK 5+, LEVEL 1 - 05700699440174

S7730 QUALICHECK5+, level 1 RED box of 30 ampoules. For ABL5/5XX, ABL7XX, EML10X
Radiometer Medical ApS
944-017
In Commercial Distribution

  • 55700699440179 ()
  • 05700699440174 ()
944-017

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

Buprenorphine 5 Control Set - 00850624008063

BUP 5 Negative Control 3 ng/mL (2 x 15 mL), BUP 5 Positive Control 7 ng/mL (2 x 15 mL).
LIN-ZHI INTERNATIONAL, INC.
08356670190
In Commercial Distribution

  • 00850624008063 ()
08356670190

  • Buprenorphine IVD, control

React Health Phoenix 5 - 06934726614439

No Description
Longfian Scitech Co., Ltd.
SOC5100
In Commercial Distribution

  • 06934726614439 ()


  • Mobile/portable oxygen concentrator

MAXROM RING-LOC +5 PROVISIONAL - 00880304301856

No Description
Biomet Orthopedics, LLC
31-105957
In Commercial Distribution

  • 00880304301856 ()
31-105957

  • Acetabulum prosthesis trial, prefabricated, reusable

MAXROM RING-LOC +5 PROVISIONAL - 00880304301849

No Description
Biomet Orthopedics, LLC
31-105956
In Commercial Distribution

  • 00880304301849 ()
31-105956

  • Acetabulum prosthesis trial, prefabricated, reusable

MAXROM RING-LOC +5 PROVISIONAL - 00880304301832

No Description
Biomet Orthopedics, LLC
31-105955
In Commercial Distribution

  • 00880304301832 ()
31-105955

  • Acetabulum prosthesis trial, prefabricated, reusable

MAXROM RING-LOC +5 PROVISIONAL - 00880304301825

No Description
Biomet Orthopedics, LLC
31-105954
In Commercial Distribution

  • 00880304301825 ()
31-105954

  • Acetabulum prosthesis trial, prefabricated, reusable
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