Barostim

Primary DI
00859144004630
Brand
Barostim
Company
CVRX, INC.
Model
9020
Catalog number
100067-202
Device description
Model 9020 Barostim Programmer System
Published
2026-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P180050002

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P180050002BAROSTIM NEO® SystemCvrx, Inc.2019-08-16DSR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859144004630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859144004630008591440046308591440046300859144004630

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
763-416-7457acrouse@cvrx.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859144004623Barostim NEO22104100065-2022026-01-21
00859144004432BAROSTIM NEO2102100054-2022019-08-22
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
00859144004432BAROSTIM NEOCVRX, INC.DSR2019-08-22
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