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 Class Implantable

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Workstation
ST. JUDE MEDICAL, INC.
100026148
In Commercial Distribution

  • 05414734031035 ()
100026148

  • Cardiac mapping system
Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-01
In Commercial Distribution

  • 05415067032188 ()
ENSITE-R-DWS-01

  • Cardiac mapping system
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-01
In Commercial Distribution

  • 05415067032171 ()
ENSITE-DWS-01

  • Cardiac mapping system
Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-R-AMP-01
In Commercial Distribution

  • 05415067032164 ()
ENSITE-R-AMP-01

  • Cardiac mapping system
Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-AMP-01
In Commercial Distribution

  • 05415067032157 ()
ENSITE-AMP-01

  • Cardiac mapping system
AcQMap System
ACUTUS MEDICAL, INC.
900000
Not in Commercial Distribution

  • 00857042007999 ()
900000

  • Cardiac mapping system
AcQMap System Console 2.0
ACUTUS MEDICAL, INC.
900100
Not in Commercial Distribution

  • 00857042007920 ()
900100

  • Cardiac mapping system
AcQMap Ablation Reference Cable
ACUTUS MEDICAL, INC.
800505
Not in Commercial Distribution

  • 00857042007326 ()
800505

  • Cardiac mapping system
AcQMap Ablation Electrogram Cable
ACUTUS MEDICAL, INC.
800508
Not in Commercial Distribution

  • 00857042007319 ()
800508

  • Cardiac mapping system
AcQMap Auxiliary Interface Box
ACUTUS MEDICAL, INC.
800422
Not in Commercial Distribution

  • 00857042007302 ()
800422

  • Cardiac mapping system
AcQMap Console
ACUTUS MEDICAL, INC.
800500
Not in Commercial Distribution

  • 00857042007296 ()
800500

  • Cardiac mapping system
AcQMap Workstation
ACUTUS MEDICAL, INC.
800520
Not in Commercial Distribution

  • 00857042007289 ()
800520

  • Cardiac mapping system
AcQMap 2mm Pin Jumper St
ACUTUS MEDICAL, INC.
800523
Not in Commercial Distribution

  • 00857042007272 ()
800523

  • Cardiac mapping system
AcQMap ECG w/Snaps Cable
ACUTUS MEDICAL, INC.
800522
Not in Commercial Distribution

  • 00857042007265 ()
800522

  • Cardiac mapping system
AcQMap ECG POST Cable
ACUTUS MEDICAL, INC.
800524
Not in Commercial Distribution

  • 00857042007258 ()
800524

  • Cardiac mapping system
AcQMap ECG Input Cable
ACUTUS MEDICAL, INC.
800421
Not in Commercial Distribution

  • 00857042007241 ()
800421

  • Cardiac mapping system
AcQMap ECG Output Cable
ACUTUS MEDICAL, INC.
800424
Not in Commercial Distribution

  • 00857042007234 ()
800424

  • Cardiac mapping system
Ampere® Adapter Cable AcQMap® Ampere
ACUTUS MEDICAL, INC.
800431
Not in Commercial Distribution

  • 00857042007135 ()
800431

  • Cardiac mapping system
AcQMap® Surface ECG Cable
ACUTUS MEDICAL, INC.
800407
Not in Commercial Distribution

  • 00857042007128 ()
800407

  • Cardiac mapping system
AcQMap® Auxiliary Catheter Cable
ACUTUS MEDICAL, INC.
800109
Not in Commercial Distribution

  • 00857042007111 ()
800109

  • Cardiac mapping system
AcQMap® Ablation Interface Unit Cable
ACUTUS MEDICAL, INC.
800112
Not in Commercial Distribution

  • 00857042007104 ()
800112

  • Cardiac mapping system
AcQMap® Patient Interface Unit Cable
ACUTUS MEDICAL, INC.
800113
Not in Commercial Distribution

  • 00857042007098 ()
800113

  • Cardiac mapping system
AcQMap® Patient Interface Unit
ACUTUS MEDICAL, INC.
800229
Not in Commercial Distribution

  • 00857042007081 ()
800229

  • Cardiac mapping system
Ampere® Adapter Cable AcQMap® Ablation Catheter
ACUTUS MEDICAL, INC.
800430
Not in Commercial Distribution

  • 00857042007074 ()
800430

  • Cardiac mapping system
AcQMap® Ablation Interface Unit
ACUTUS MEDICAL, INC.
800244-001
Not in Commercial Distribution

  • 00857042007067 ()
800244-001

  • Cardiac mapping system
AcQMap® Workstation
ACUTUS MEDICAL, INC.
800254
Not in Commercial Distribution

  • 00857042007050 ()
800254

  • Cardiac mapping system
AcQMap® Console
ACUTUS MEDICAL, INC.
800258
Not in Commercial Distribution

  • 00857042007043 ()
800258

  • Cardiac mapping system
North America Power Cord
ACUTUS MEDICAL, INC.
800426
Not in Commercial Distribution

  • 00857042007005 ()
800426

  • Cardiac mapping system
AcQMap to DiamondTemp Generator Adapter Cable
ACUTUS MEDICAL, INC.
800818
Not in Commercial Distribution

  • 00850027837635 ()
800818

  • Cardiac mapping system
AcQMap to DiamondTemp Generator Adapter
ACUTUS MEDICAL, INC.
800727
Not in Commercial Distribution

  • 00850027837253 ()
800727

  • Cardiac mapping system
X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-3.1
In Commercial Distribution

  • 05415067051165 ()
ENSITE-SYSTEM-3.1

  • Cardiac mapping system
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-3.1
In Commercial Distribution

  • 05415067051141 ()
ENSITE-R-DWS-3.1

  • Cardiac mapping system
X EP System
ST. JUDE MEDICAL, INC.
ENSITE-R-SYS-3.1
In Commercial Distribution

  • 05415067051134 ()
ENSITE-R-SYS-3.1

  • Cardiac mapping system
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-3.1
In Commercial Distribution

  • 05415067051127 ()
ENSITE-DWS-3.1

  • Cardiac mapping system
X Amplifier Air Filter
ST. JUDE MEDICAL, INC.
ENSITE-AAF-01
In Commercial Distribution

  • 05415067048721 ()
ENSITE-AAF-01

  • Cardiac mapping system
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-2.0.1
In Commercial Distribution

  • 05415067046710 ()
ENSITE-DWS-2.0.1

  • Cardiac mapping system
X EP System EnSite Cloud Software License
ST. JUDE MEDICAL, INC.
ENSITE-CL-01
In Commercial Distribution

  • 05415067046697 ()
ENSITE-CL-01

  • Cardiac mapping system
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-2.0.1
In Commercial Distribution

  • 05415067046680 ()
ENSITE-R-DWS-2.0.1

  • Cardiac mapping system
X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-201
In Commercial Distribution

  • 05415067046666 ()
ENSITE-SYSTEM-201

  • Cardiac mapping system
X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-111
In Commercial Distribution

  • 05415067041722 ()
ENSITE-SYSTEM-111

  • Cardiac mapping system
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