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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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uCor Heart Failure and Arrhythmia Management System - 00855778005326

No Description
ZOLL MANUFACTURING CORPORATION
Gateway
In Commercial Distribution

  • 00855778005326 ()
10A1073

  • Wearable multiple vital physiological parameter monitoring system

ZOLL Charger - 00855778005319

No Description
ZOLL MANUFACTURING CORPORATION
Charger
In Commercial Distribution

  • 00855778005319 ()
10A1072

  • Wearable multiple vital physiological parameter monitoring system

uCor Heart Failure and Arrhythmia Management System - 00855778005302

No Description
ZOLL MANUFACTURING CORPORATION
Sensor
In Commercial Distribution

  • 00855778005302 ()
10A1071

  • Wearable multiple vital physiological parameter monitoring system

ZOLL Patch - 00855778005258

No Description
ZOLL MANUFACTURING CORPORATION
Patch
In Commercial Distribution

  • 00855778005258 ()
10A1067

  • Wearable multiple vital physiological parameter monitoring system

Iradimed - 00856038001218

MRI Monitor Remote Base/Charger
IRADIMED CORP.
3885B
In Commercial Distribution

  • 00856038001218 ()
3885B

  • Centralized patient monitor

AcQMap - 00857042007999

AcQMap System
ACUTUS MEDICAL, INC.
900000
Not in Commercial Distribution

  • 00857042007999 ()
900000

  • Cardiac mapping system

AcQMap - 00857042007920

AcQMap System Console 2.0
ACUTUS MEDICAL, INC.
900100
Not in Commercial Distribution

  • 00857042007920 ()
900100

  • Cardiac mapping system

AcQMap - 00857042007326

AcQMap Ablation Reference Cable
ACUTUS MEDICAL, INC.
800505
Not in Commercial Distribution

  • 00857042007326 ()
800505

  • Cardiac mapping system

AcQMap - 00857042007319

AcQMap Ablation Electrogram Cable
ACUTUS MEDICAL, INC.
800508
Not in Commercial Distribution

  • 00857042007319 ()
800508

  • Cardiac mapping system

AcQMap - 00857042007302

AcQMap Auxiliary Interface Box
ACUTUS MEDICAL, INC.
800422
Not in Commercial Distribution

  • 00857042007302 ()
800422

  • Cardiac mapping system

AcQMap - 00857042007296

AcQMap Console
ACUTUS MEDICAL, INC.
800500
Not in Commercial Distribution

  • 00857042007296 ()
800500

  • Cardiac mapping system

AcQMap - 00857042007289

AcQMap Workstation
ACUTUS MEDICAL, INC.
800520
Not in Commercial Distribution

  • 00857042007289 ()
800520

  • Cardiac mapping system

AcQMap - 00857042007272

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

  • 00857042007272 ()
800523

  • Cardiac mapping system

AcQMap - 00857042007265

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

  • 00857042007265 ()
800522

  • Cardiac mapping system

AcQMap - 00857042007258

AcQMap ECG POST Cable
ACUTUS MEDICAL, INC.
800524
Not in Commercial Distribution

  • 00857042007258 ()
800524

  • Cardiac mapping system

AcQMap - 00857042007241

AcQMap ECG Input Cable
ACUTUS MEDICAL, INC.
800421
Not in Commercial Distribution

  • 00857042007241 ()
800421

  • Cardiac mapping system

AcQMap - 00857042007234

AcQMap ECG Output Cable
ACUTUS MEDICAL, INC.
800424
Not in Commercial Distribution

  • 00857042007234 ()
800424

  • Cardiac mapping system

AcQMap - 00857042007135

Ampere® Adapter Cable AcQMap® Ampere
ACUTUS MEDICAL, INC.
800431
Not in Commercial Distribution

  • 00857042007135 ()
800431

  • Cardiac mapping system

AcQMap - 00857042007128

AcQMap® Surface ECG Cable
ACUTUS MEDICAL, INC.
800407
Not in Commercial Distribution

  • 00857042007128 ()
800407

  • Cardiac mapping system

AcQMap - 00857042007111

AcQMap® Auxiliary Catheter Cable
ACUTUS MEDICAL, INC.
800109
Not in Commercial Distribution

  • 00857042007111 ()
800109

  • Cardiac mapping system

AcQMap - 00857042007104

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

  • 00857042007104 ()
800112

  • Cardiac mapping system

AcQMap - 00857042007098

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

  • 00857042007098 ()
800113

  • Cardiac mapping system

AcQMap - 00857042007081

AcQMap® Patient Interface Unit
ACUTUS MEDICAL, INC.
800229
Not in Commercial Distribution

  • 00857042007081 ()
800229

  • Cardiac mapping system

AcQMap - 00857042007074

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

  • 00857042007074 ()
800430

  • Cardiac mapping system

AcQMap - 00857042007067

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

  • 00857042007067 ()
800244-001

  • Cardiac mapping system

AcQMap - 00857042007050

AcQMap® Workstation
ACUTUS MEDICAL, INC.
800254
Not in Commercial Distribution

  • 00857042007050 ()
800254

  • Cardiac mapping system

AcQMap - 00857042007043

AcQMap® Console
ACUTUS MEDICAL, INC.
800258
Not in Commercial Distribution

  • 00857042007043 ()
800258

  • Cardiac mapping system

AcQMap - 00857042007005

North America Power Cord
ACUTUS MEDICAL, INC.
800426
Not in Commercial Distribution

  • 00857042007005 ()
800426

  • Cardiac mapping system

740 SELECT - 00851920007446

The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
740 SELECT-0N0E0
In Commercial Distribution

  • 00851920007446 ()
01-02-1025

  • Multiple vital physiological parameter monitoring system, clinical

740 SELECT - 00851920007422

The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
740 SELECT-XN0EW
In Commercial Distribution

  • 00851920007422 ()
01-02-1049

  • Multiple vital physiological parameter monitoring system, clinical

740 SELECT - 00851920007415

The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
740 SELECT-XM0EW
In Commercial Distribution

  • 00851920007415 ()
01-02-1048

  • Multiple vital physiological parameter monitoring system, clinical

740 SELECT - 00851920007408

The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
740 SELECT-XMF0W
In Commercial Distribution

  • 00851920007408 ()
01-02-1033

  • Multiple vital physiological parameter monitoring system, clinical

740 SELECT - 00851920007392

The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
740 SELECT-XNFE0
In Commercial Distribution

  • 00851920007392 ()
01-02-1021

  • Multiple vital physiological parameter monitoring system, clinical

740 SELECT - 00851920007385

The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
740 SELECT-0NF00
In Commercial Distribution

  • 00851920007385 ()
01-02-1014

  • Multiple vital physiological parameter monitoring system, clinical

DM4 - 00851920007378

The DM4 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
91331-MFW
In Commercial Distribution

  • 00851920007378 ()
91331-MFW

  • Multiple vital physiological parameter monitoring system, clinical

DM4 - 00851920007361

The DM4 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
91331-MW
In Commercial Distribution

  • 00851920007361 ()
91331-MW

  • Multiple vital physiological parameter monitoring system, clinical

DM4 - 00851920007354

The DM4 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
91331-MF
In Commercial Distribution

  • 00851920007354 ()
91331-MF

  • Multiple vital physiological parameter monitoring system, clinical

DM4 - 00851920007347

The DM4 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
91331-M
In Commercial Distribution

  • 00851920007347 ()
91331-M

  • Multiple vital physiological parameter monitoring system, clinical

DM4 - 00851920007330

The DM4 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
91331-NFW
In Commercial Distribution

  • 00851920007330 ()
91331-NFW

  • Multiple vital physiological parameter monitoring system, clinical

DM4 - 00851920007323

The DM4 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
91331-NW
In Commercial Distribution

  • 00851920007323 ()
91331-NW

  • Multiple vital physiological parameter monitoring system, clinical

DM4 - 00851920007316

The DM4 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
91331-NF
In Commercial Distribution

  • 00851920007316 ()
91331-NF

  • Multiple vital physiological parameter monitoring system, clinical

DM4 - 00851920007309

The DM4 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
91331-N
In Commercial Distribution

  • 00851920007309 ()
91331-N

  • Multiple vital physiological parameter monitoring system, clinical

740 SELECT - 00851920007293

The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
740 SELECT-X0A00
In Commercial Distribution

  • 00851920007293 ()
01-02-1010

  • Multiple vital physiological parameter monitoring system, clinical

740 SELECT - 00851920007132

The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
740 SELECT-XM0E0
In Commercial Distribution

  • 00851920007132 ()
01-02-1018

  • Multiple vital physiological parameter monitoring system, clinical

740 SELECT - 00851920007125

The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
740 SELECT-0M000
In Commercial Distribution

  • 00851920007125 ()
01-02-1015

  • Multiple vital physiological parameter monitoring system, clinical

740 SELECT - 00851920007118

The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
740 SELECT-XNA00
In Commercial Distribution

  • 00851920007118 ()
01-02-1007

  • Multiple vital physiological parameter monitoring system, clinical

740 SELECT - 00851920007101

The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
740 SELECT-XMA00
In Commercial Distribution

  • 00851920007101 ()
01-02-1006

  • Multiple vital physiological parameter monitoring system, clinical

740 SELECT - 00851920007071

The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
740 SELECT-XN000
In Commercial Distribution

  • 00851920007071 ()
01-02-1002

  • Multiple vital physiological parameter monitoring system, clinical

VistaPhone Compact Cardiac Monitoring Kit - 00850490007504

Compact Cardiac Monitoring Kit
Vital Connect, Inc.
1500-01
In Commercial Distribution

  • 00850490007504 ()
1400-02

  • Wearable multiple vital physiological parameter monitoring system

740 SELECT - 00851920007095

The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
740 SELECT-XNF00
In Commercial Distribution

  • 00851920007095 ()
01-02-1004

  • Multiple vital physiological parameter monitoring system, clinical
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