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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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CareLink® Network - 00763000017347

SW CLN CARELINK NETWORK RELEASE
MEDTRONIC, INC.
CLN
In Commercial Distribution

  • 00763000017347 ()


  • Implantable cardiac device management application software

Smart ECG - 08031527017334

MicroPort CRM Smart ECG
MICROPORT CRM SRL
K379
In Commercial Distribution

  • 08031527017334 ()
K379

  • Electrocardiographic ambulatory recorder

Saver EVO - M727SAVEREVOH013

Saver EVO is a user friendly information management program to assist users to manage data from their defibrillation device. Saver EVO shall allow the user to download the data from a HeartSine device to a PC computer. Saver EVO™ data management software enables downloading, revie wing and printing ECG waveforms and event history data recorded in HeartSine samaritan PAD devices. Features of Saver EVO include:Comprehensive event documentation to facilitate physician oversight, Utstein style reporting and report export capabilities, User configuration setup and time synchronization, Simple point-and-click operation
HEARTSINE TECHNOLOGIES LTD
1.4.0
In Commercial Distribution

  • M727SAVEREVOH013 ()
PAD-ACC-03

  • External defibrillator application software

BAROSTIM NEO - 00859144004470

BAROSTIM NEO Model 1037 Carotid Sinus Lead Kit
CVRX, INC.
1037
In Commercial Distribution

  • 00859144004470 ()
100063-222

  • Baroreceptor electrical stimulation system

BAROSTIM NEO - 00859144004463

BAROSTIM NEO Model 1036 Carotid Sinus Lead Kit (US Commercial)
CVRX, INC.
1036
In Commercial Distribution

  • 00859144004463 ()
100063-212

  • Baroreceptor electrical stimulation system

BAROSTIM Lead Repair Kit - 00859144004456

Model 5010 Carotid Sinus Lead Repair Kit (US Commercial)
CVRX, INC.
5010
In Commercial Distribution

  • 00859144004456 ()
100056-202

  • Baroreceptor electrical stimulation system

BAROSTIM Programmer - 00859144004449

Model 9010 Programmer System (US Commercial)
CVRX, INC.
9010
In Commercial Distribution

  • 00859144004449 ()
100055-202

  • Baroreceptor electrical stimulation system

BAROSTIM NEO - 00859144004432

BAROSTIM NEO Model 2102 Implantable Pulse Generator (US Commercial)
CVRX, INC.
2102
In Commercial Distribution

  • 00859144004432 ()
100054-202

  • Baroreceptor electrical stimulation system

NA - 00859144004234

Accessory Kit
CVRX, INC.
5500
In Commercial Distribution

  • 00859144004234 ()
100033-301

  • Baroreceptor electrical stimulation system

NA - 00859144004227

Magnet
CVRX, INC.
5000
In Commercial Distribution

  • 00859144004227 ()
100034-301

  • Baroreceptor electrical stimulation system
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