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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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ECG Cables and Leadsets - 20884838006793

Preattached leadwire electrode, Square Radiolucent carbon AAMI color 45cm/18" leadwires with 1.5mm/.060" safety socket square 22cm x 22cm cloth backing with Ag/Cl sensor, 3/pouch, 300/case.
Philips Medical Systems Hsg
Preattached leadwire electrode, Square
In Commercial Distribution

  • 20884838006793 ()
  • 10884838006796 ()
989803100551

  • Electrocardiographic electrode, single-use

NA - 20673978538383

CELL 1473R1 TMC25 W/6 IN EXTENSION
MEDTRONIC, INC.
1473R1
In Commercial Distribution

  • 20673978538383 ()
  • 00673978538389 ()


  • Extracorporeal membrane oxygenator

CDI OneView™ Monitoring System - 00886799002049

CDI OneView™ Touchscreen Display
Terumo Cardiovascular Systems Corporation
CDI751
In Commercial Distribution

  • 00886799002049 ()
CDI751

  • Extracorporeal blood gas/pH monitor

CDI OneView™ Monitoring System - 00886799002032

CDI OneView™ Core
Terumo Cardiovascular Systems Corporation
CDI750
In Commercial Distribution

  • 00886799002032 ()
CDI750

  • Extracorporeal blood gas/pH monitor

CDI OneView™ Monitoring System - 00886799002025

Calibrator Mounting Arm Bracket
Terumo Cardiovascular Systems Corporation
CDI783
In Commercial Distribution

  • 00886799002025 ()
CDI783

  • Portable active medical device mount

CDI OneView™ Monitoring System - 00886799002018

BPM Mounting Arm Bracket
Terumo Cardiovascular Systems Corporation
CDI782
In Commercial Distribution

  • 00886799002018 ()
CDI782

  • Portable active medical device mount

CDI OneView™ Monitoring System - 00886799002001

Display Mounting Arm Bracket
Terumo Cardiovascular Systems Corporation
CDI781
In Commercial Distribution

  • 00886799002001 ()
CDI781

  • Portable active medical device mount

CDI OneView™ Monitoring System - 00886799001998

Core Mounting Arm Bracket
Terumo Cardiovascular Systems Corporation
CDI780
In Commercial Distribution

  • 00886799001998 ()
CDI780

  • Portable active medical device mount

CDI OneView™ Monitoring System - 00886799001981

CDI OneView™ Calibrator Cable
Terumo Cardiovascular Systems Corporation
CDI741
In Commercial Distribution

  • 00886799001981 ()
CDI741

  • Electrical-only medical device connection cable, reusable

CDI OneView™ Monitoring System - 00886799001974

CDI OneView™ Flow Sensor 1/4" x 1/16"
Terumo Cardiovascular Systems Corporation
CDI768
In Commercial Distribution

  • 00886799001974 ()
CDI768

  • Cardiopulmonary bypass system pressure monitor

CDI OneView™ Monitoring System - 00886799001967

CDI OneView™ Flow Sensor 1/4" x 3/32"
Terumo Cardiovascular Systems Corporation
CDI764
In Commercial Distribution

  • 00886799001967 ()
CDI764

  • Cardiopulmonary bypass system pressure monitor

CDI OneView™ Monitoring System - 00886799001950

CDI OneView™ Flow Sensor 3/8" x 3/32"
Terumo Cardiovascular Systems Corporation
CDI763
In Commercial Distribution

  • 00886799001950 ()
CDI763

  • Cardiopulmonary bypass system pressure monitor

CDI OneView™ Monitoring System - 00886799001943

CDI OneView™ EDM RSO2 Interface Module
Terumo Cardiovascular Systems Corporation
CDI772
In Commercial Distribution

  • 00886799001943 ()
CDI772

  • Patient monitoring system module, interfacing

CDI OneView™ Monitoring System - 00886799001936

CDI OneView™ EDM DMS Interface Module
Terumo Cardiovascular Systems Corporation
CDI771
In Commercial Distribution

  • 00886799001936 ()
CDI771

  • Patient monitoring system module, interfacing

CDI OneView™ Monitoring System - 00886799001929

CDI OneView™ Flow Interface Module
Terumo Cardiovascular Systems Corporation
CDI760
In Commercial Distribution

  • 00886799001929 ()
CDI760

  • Patient monitoring system module, interfacing

CDI OneView™ Monitoring System - 00886799001912

CDI OneView™ EDM HLM Interface Module
Terumo Cardiovascular Systems Corporation
CDI770
In Commercial Distribution

  • 00886799001912 ()
CDI770

  • Patient monitoring system module, interfacing

CDI OneView™ Monitoring System - 00886799001905

CDI OneView™ Calibrator
Terumo Cardiovascular Systems Corporation
CDI740
In Commercial Distribution

  • 00886799001905 ()
CDI740

  • Extracorporeal blood gas/pH monitor

CDI OneView™ Monitoring System - 00886799001899

CDI OneView™ BPM Probe
Terumo Cardiovascular Systems Corporation
CDI753
In Commercial Distribution

  • 00886799001899 ()
CDI753

  • Extracorporeal blood gas/pH monitor

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

NORDENT MANUFACTURING INC - 00840018619302

SCALER, DOUBLE END,OFFSET SICKLE MONTANA JACK-20, DURALITE COLOR RINGS HANDLE
NORDENT MANUFACTURING INC
CESCNMJ-20
In Commercial Distribution

  • 00840018619302 ()


  • Manual dental scaler, reusable

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 - 00883873863084

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

  • 00883873863084 ()
21996-000104

  • 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 - 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

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 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 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
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