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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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VU - 00860009142916

The VU System provides real-time images of the contact pressure profile under a patient in a bed-care setting. This feedback helps caregivers to successfully offload pressure, which substantially reduces the risk of pressure injuries. This product version is designed for use on bariatric beds / patients.
Wellsense, Inc.
WS-MAT-200-04
In Commercial Distribution

  • 00860009142916 ()


  • Body-surface pressure mapping system

VU - 00860009142909

The VU System provides real-time images of the contact pressure profile under a patient in a bed-care setting. This feedback helps caregivers to successfully offload pressure, which substantially reduces the risk of pressure injuries.
Wellsense, Inc.
WS-MAT-200-02
In Commercial Distribution

  • 00860009142909 ()


  • Body-surface pressure mapping system

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

Neo Legacy - 00859144004210

Neo Legacy Implantable Pulse Generator
CVRX, INC.
2100
In Commercial Distribution

  • 00859144004210 ()
100053-301

  • Baroreceptor electrical stimulation system
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