FDA.reportPublic FDA data

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

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