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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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CDI OneView™ Monitoring System - 00886799001882

CDI OneView™ H/S Probe
Terumo Cardiovascular Systems Corporation
CDI754
In Commercial Distribution

  • 00886799001882 ()
CDI754

  • Extracorporeal blood gas/pH monitor

CDI® Blood Parameter Monitoring System 550 - 00886799001790

Monitor with one blood parameter module and one H/S Probe.
Terumo Cardiovascular Systems Corporation
550AHCT
In Commercial Distribution

  • 00886799001790 ()
550AHCT

  • Extracorporeal blood gas/pH monitor

CDI® Blood Parameter Monitoring System 550 - 00886799001783

Monitor with two blood parameter modules and one H/S Probe.
Terumo Cardiovascular Systems Corporation
550AVHCT
In Commercial Distribution

  • 00886799001783 ()
550AVHCT

  • Extracorporeal blood gas/pH monitor

CDI™ Blood Parameter Monitoring System 500 - 00886799001738

Interface cable for Jostra HL 20
Terumo Cardiovascular Systems Corporation
158828
In Commercial Distribution

  • 00886799001738 ()
158828

  • Cardiopulmonary bypass system mounting unit

CDI™ Blood Parameter Monitoring System 500 - 00886799001646

Monitor with two blood parameter modules and one H/S Probe.
Terumo Cardiovascular Systems Corporation
500AVHCT
In Commercial Distribution

  • 00886799001646 ()
500AVHCT

  • Extracorporeal blood gas/pH monitor

CDI™ Blood Parameter Monitoring System 500 - 00886799001639

Monitor with two blood parameter modules.
Terumo Cardiovascular Systems Corporation
500AV
In Commercial Distribution

  • 00886799001639 ()
500AV

  • Extracorporeal blood gas/pH monitor

CDI™ Blood Parameter Monitoring System 500 - 00886799001622

Monitor with one blood parameter module and one H/S Probe.
Terumo Cardiovascular Systems Corporation
500AHCT
In Commercial Distribution

  • 00886799001622 ()
500AHCT

  • Extracorporeal blood gas/pH monitor

CDI™ Blood Parameter Monitoring System 500 - 00886799001615

Monitor with one blood parameter module.
Terumo Cardiovascular Systems Corporation
500A
In Commercial Distribution

  • 00886799001615 ()
500A

  • Extracorporeal blood gas/pH monitor

CDI™ Blood Parameter Monitoring System 500 - 00886799000410

Interface cable for Meditronic Bio-Console 550
Terumo Cardiovascular Systems Corporation
151861
In Commercial Distribution

  • 00886799000410 ()
151861

  • Cardiopulmonary bypass system mounting unit

CDI™ Blood Parameter Monitoring System 500 - 00886799000403

Interface cable for TCVS Sarns Centrifugal Pump
Terumo Cardiovascular Systems Corporation
151853
In Commercial Distribution

  • 00886799000403 ()
151853

  • Cardiopulmonary bypass system mounting unit

CDI™ Blood Parameter Monitoring System 500 - 00886799000397

Interface cable for TCVS Sarns 8000
Terumo Cardiovascular Systems Corporation
151829
In Commercial Distribution

  • 00886799000397 ()
151829

  • Cardiopulmonary bypass system mounting unit

CDI™ Blood Parameter Monitoring System 500 - 00886799000007

Calibrator, for use with the CDI Model 500 Monitor
Terumo Cardiovascular Systems Corporation
540
In Commercial Distribution

  • 00886799000007 ()
540

  • Extracorporeal blood gas/pH monitor

BMU 40 - 04037691349251

No Description
Maquet Cardiopulmonary AG
BMU 40 Cell 1/2"
Not in Commercial Distribution

  • 04037691349190 ()
  • 04037691349251 ()

  • Length: 102.7 Millimeter
  • Outer Diameter: 0.5 Inch
70104.0804

  • Cardiopulmonary bypass system blood gas sensor

LIFENET Connect - 00883873952863

LIFENET Connect RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873952863 ()
21340-000606

  • Emergency/ambulatory healthcare software

LIFENET Connect Gateway - 00883873952856

LIFENET Connect Gateway RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873952856 ()
21340-000607

  • Emergency/ambulatory healthcare software

LIFENET PC Gateway - 00883873908181

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 - 00883873907870

LIFENET Export 32-BIT RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873907870 ()
21340-000778

  • Emergency/ambulatory healthcare software

LIFENET Export 64-BIT - 00883873907863

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

  • 00883873907863 ()
21340-000779

  • Emergency/ambulatory healthcare software

LIFENET Adapter 32-BIT - 00883873903438

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 - 00883873903421

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 - 00883873903278

LIFENET SERVER
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873903278 ()
21340-000796

  • Emergency/ambulatory healthcare software

LIFENET ALERT 32-BIT - 00883873901878

LIFENET ALERT 32-BIT
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873901878 ()
21340-000800

  • Emergency/ambulatory healthcare software

LIFENET ALERT 64-BIT - 00883873901861

LIFENET ALERT 64-BIT
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873901861 ()
21340-000801

  • Emergency/ambulatory healthcare software

LIFENET Mobile Gateway - 00883873889749

LIFENET Mobile Gateway RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873889749 ()
21340-000824

  • Emergency/ambulatory healthcare software

LIFENET CONSULT - 00883873863770

LIFENET CONSULT RELEASE5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873863770 ()
21340-000837

  • Emergency/ambulatory healthcare software

LIFENET CONSULT INTERNATIONAL - 00883873863732

LIFENET CONSULT INTERNATIONAL RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873863732 ()
21340-000838

  • Emergency/ambulatory healthcare software

MULTITECH 3G GATEWAY - ATT KORE - 00883873863077

MULTITECH 3G GATEWAY - ATT KORE
PHYSIO-CONTROL, INC.
21996
Not in Commercial Distribution

  • 00883873863077 ()
21996-000105

  • Emergency/ambulatory healthcare software

MULTITECH 3G GATEWAY - ATT - 00883873863084

MULTITECH 3G GATEWAY - ATT
PHYSIO-CONTROL, INC.
21996
Not in Commercial Distribution

  • 00883873863084 ()
21996-000104

  • Emergency/ambulatory healthcare software

MULTITECH 3G GATEWAY - VERIZON - 00883873863060

MULTITECH 3G GATEWAY - VERIZON
PHYSIO-CONTROL, INC.
21996
Not in Commercial Distribution

  • 00883873863060 ()
21996-000106

  • Emergency/ambulatory healthcare software

MULTITECH 3G GATEWAY - VERIZON KORE - 00883873863053

MULTITECH 3G GATEWAY - VERIZON KORE
PHYSIO-CONTROL, INC.
21996
Not in Commercial Distribution

  • 00883873863053 ()
21996-000107

  • Emergency/ambulatory healthcare software

MULTITECH 3G GATEWAY - INTL - 00883873863046

MULTITECH 3G GATEWAY - INTL
PHYSIO-CONTROL, INC.
21996
Not in Commercial Distribution

  • 00883873863046 ()
21996-000108

  • Emergency/ambulatory healthcare software

LIFENET ASSET EXPORT 32-BIT - 00883873862902

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 - 00883873862896

LIFENET ASSET EXPORT 64-BIT 5.4.1.2
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873862896 ()
21340-000844

  • Emergency/ambulatory healthcare software

PHILIPS HeartStart Configure - 00884838041547

HeartStart Configure
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
HeartStart Configure
In Commercial Distribution

  • 00884838041547 ()
861487

  • Emergency/ambulatory healthcare software

H2H Substitution Filter - 00896241002077

H2H Substitution Filter and packaging information
NEPHROS, INC.
70-6828
Not in Commercial Distribution

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


  • Haemodialysis system dialysate pyrogen-filtration set

ONLINE TDM Carbamazepine Gen4 - 04015630936885

No Description
Roche Diagnostics GmbH
7258062190
In Commercial Distribution

  • 04015630936885 ()
7258062190

  • Carbamazepine therapeutic drug monitoring IVD, kit, fluorescent immunoassay

ONLINE TDM Acetaminophen Gen2 - 04015630935031

No Description
Roche Diagnostics GmbH
6769942190
In Commercial Distribution

  • 04015630935031 ()
6769942190

  • Acetaminophen IVD, kit, spectrophotometry

ONLINE DAT Benzodiazepines II - 04015630999347

No Description
Roche Diagnostics GmbH
04939417190
In Commercial Distribution

  • 04015630999347 ()
04939417190

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)

Vancomycin ONLINE TDM Vancomycin - 04015630997978

No Description
Roche Diagnostics GmbH
4642481190
Not in Commercial Distribution

  • 04015630997978 ()
4642481190

  • Vancomycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Vancomycin ONLINE TDM Vancomycin - 04015630997961

No Description
Roche Diagnostics GmbH
4642490190
Not in Commercial Distribution

  • 04015630997961 ()
4642490190

  • Vancomycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
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