100034-301

GUDID 00859144004227

Magnet

CVRX, INC.

Baroreceptor electrical stimulation system

• Primary Device ID: 00859144004227
• NIH Device Record Key: b8fde2a8-c5aa-4ae2-af86-e593e8af18cb
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5000
• Catalog Number: 100034-301
• Company DUNS: 052373680
• Company Name: CVRX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859144004227 [Primary]

FDA Product Code

• DSR: Stimulator, Carotid Sinus Nerve

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-01-21

Devices Manufactured by CVRX, INC.

• 00859144004432 - BAROSTIM NEO: 2019-08-30 BAROSTIM NEO Model 2102 Implantable Pulse Generator (US Commercial)
• 00859144004449 - BAROSTIM Programmer: 2019-08-30 Model 9010 Programmer System (US Commercial)
• 00859144004456 - BAROSTIM Lead Repair Kit: 2019-08-30 Model 5010 Carotid Sinus Lead Repair Kit (US Commercial)
• 00859144004463 - BAROSTIM NEO: 2019-08-30 BAROSTIM NEO Model 1036 Carotid Sinus Lead Kit (US Commercial)
• 00859144004470 - BAROSTIM NEO: 2019-08-30 BAROSTIM NEO Model 1037 Carotid Sinus Lead Kit
• 00859144004128 - NA: 2018-03-29 Programmer System
• 00859144004203 - NA: 2018-03-29 Carotid Sinus Lead Repair Kit
• 00859144004210 - Neo Legacy: 2018-03-29 Neo Legacy Implantable Pulse Generator