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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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LIFENET ASSET EXPORT 32-BIT 5.4.1.2
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873862902 ()
21340-000843

  • Emergency/ambulatory healthcare software
LIFENET ASSET EXPORT 64-BIT 5.4.1.2
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873862896 ()
21340-000844

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

  • 00883873908181 ()
21340-000769

  • Emergency/ambulatory healthcare software
LIFENET Export 32-BIT RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873907870 ()
21340-000778

  • Emergency/ambulatory healthcare software
LIFENET Adapter 32-BIT RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873903438 ()
21340-000794

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

  • 00883873952863 ()
21340-000606

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

  • 00883873952856 ()
21340-000607

  • Emergency/ambulatory healthcare software
LIFENET Export 64-BIT RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873907863 ()
21340-000779

  • Emergency/ambulatory healthcare software
HeartStart Configure
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
HeartStart Configure
In Commercial Distribution

  • 00884838041547 ()
861487

  • 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
6769942190
In Commercial Distribution

  • 04015630935031 ()
6769942190

  • Acetaminophen IVD, kit, spectrophotometry
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
4642490190
Not in Commercial Distribution

  • 04015630997961 ()
4642490190

  • Vancomycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
4642503190
Not in Commercial Distribution

  • 04015630997930 ()
4642503190

  • Tobramycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
08058644190
In Commercial Distribution

  • 07613336121511 ()
08058644190

  • Cannabinoid/cannabinoid metabolite IVD, reagent
No Description
Roche Diagnostics GmbH
08058130190
In Commercial Distribution

  • 07613336121450 ()
08058130190

  • Phencyclidine (PCP) IVD, reagent
No Description
Roche Diagnostics GmbH
08058113190
In Commercial Distribution

  • 07613336121443 ()
08058113190

  • Morphine/morphine metabolite IVD, reagent
No Description
Roche Diagnostics GmbH
08058008190
In Commercial Distribution

  • 07613336121405 ()
08058008190

  • Methadone IVD, reagent
No Description
Roche Diagnostics GmbH
08056927190
In Commercial Distribution

  • 07613336121054 ()
08056927190

  • Benzodiazepine group IVD, reagent
No Description
Roche Diagnostics GmbH
08056889190
In Commercial Distribution

  • 07613336121030 ()
08056889190

  • Barbiturate IVD, reagent
No Description
Roche Diagnostics GmbH
08056781190
In Commercial Distribution

  • 07613336120996 ()
08056781190

  • Amphetamine/methamphetamine group IVD, reagent
No Description
Roche Diagnostics GmbH
08056919190
In Commercial Distribution

  • 07613336170502 ()
08056919190

  • Benzodiazepine group IVD, reagent
No Description
Roche Diagnostics GmbH
08771669190
Not in Commercial Distribution

  • 07613336166239 ()
08771669190

  • Cannabinoid/cannabinoid metabolite IVD, reagent
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