BAROSTIM NEO

Primary DI
00859144004432
Brand
BAROSTIM NEO
Company
CVRX, INC.
Model
2102
Catalog number
100054-202
Device description
BAROSTIM NEO Model 2102 Implantable Pulse Generator (US Commercial)
Published
2019-08-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSRStimulator, Carotid Sinus Nerve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSRStimulator, Carotid Sinus NerveCardiovascular3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859144004432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859144004432008591440044328591440044320859144004432

GMDN Terms#

Term, Definition table
TermDefinition
Baroreceptor electrical stimulation systemAn assembly of devices intended to apply electrical stimuli to baroreceptors, within the carotid sinus, as therapy for hypertension; it may additionally be intended to stimulate baroreceptors outside of the carotid sinus and as therapy for other disorders (e.g., heart failure, chronic kidney disease) in the absence of hypertension. It includes an implantable assembly [i.e., pulse generator and electrode(s)/lead(s)], an external programmer intended to communicate with the pulse generator wirelessly, and may include other supportive devices (e.g., computer, software, disposable implantation devices).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7634167457acrouse@cvrx.com

Regulatory Flags#

DUNS number
052373680
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859144004623Barostim NEO22104100065-2022026-01-21
00859144004630Barostim9020100067-2022026-01-21
00859144004470BAROSTIM NEO1037100063-2222019-08-22
00859144004128NA9010100055-1022015-01-21
00859144004227NA5000100034-3012015-01-21
00859144004234NA5500100033-3012015-01-21
00859144004449BAROSTIM Programmer9010100055-2022019-08-22
00859144004456BAROSTIM Lead Repair Kit5010100056-2022019-08-22
00859144004463BAROSTIM NEO1036100063-2122019-08-22
00859144004203NA5010100056-3012015-01-21
00859144004210Neo Legacy2100100053-3012015-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859144004623Barostim NEO2CVRX, INC.DSR2026-01-21
00859144004630BarostimCVRX, INC.DSR2026-01-21
00859144004449BAROSTIM ProgrammerCVRX, INC.DSR2019-08-22
00859144004456BAROSTIM Lead Repair KitCVRX, INC.DSR2019-08-22
00859144004463BAROSTIM NEOCVRX, INC.DSR2019-08-22
00859144004470BAROSTIM NEOCVRX, INC.DSR2019-08-22
00859144004128NACVRX, INC.DSR2015-01-21
00859144004203NACVRX, INC.DSR2015-01-21
00859144004210Neo LegacyCVRX, INC.DSR2015-01-21
00859144004227NACVRX, INC.DSR2015-01-21
00859144004234NACVRX, INC.DSR2015-01-21