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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LIFENET Adapter 64-BIT RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873903421 ()
21340-000795

  • Emergency/ambulatory healthcare software
LIFENET SERVER
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873903278 ()
21340-000796

  • Emergency/ambulatory healthcare software
LIFENET ALERT 32-BIT
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873901878 ()
21340-000800

  • Emergency/ambulatory healthcare software
LIFENET ALERT 64-BIT
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873901861 ()
21340-000801

  • Emergency/ambulatory healthcare software
LIFENET Mobile Gateway RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873889749 ()
21340-000824

  • Emergency/ambulatory healthcare software
H2H Substitution Filter and packaging information
NEPHROS, INC.
70-6828
Not in Commercial Distribution

  • 10896241002074 ()
  • 00896241002077 ()
  • 20896241002071 ()


  • Haemodialysis system dialysate pyrogen-filtration set
No Description
Roche Diagnostics GmbH
7258062190
In Commercial Distribution

  • 04015630936885 ()
7258062190

  • Carbamazepine therapeutic drug monitoring IVD, kit, fluorescent immunoassay
No Description
Roche Diagnostics GmbH
04939417190
In Commercial Distribution

  • 04015630999347 ()
04939417190

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
4642481190
Not in Commercial Distribution

  • 04015630997978 ()
4642481190

  • Vancomycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
6769942190
In Commercial Distribution

  • 04015630935031 ()
6769942190

  • Acetaminophen IVD, kit, spectrophotometry
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