BAROSTIM NEO 100063-212

GUDID 00859144004463

BAROSTIM NEO Model 1036 Carotid Sinus Lead Kit (US Commercial)

CVRX, INC.

Baroreceptor electrical stimulation system

• Primary Device ID: 00859144004463
• NIH Device Record Key: ef038340-cee7-48da-8987-2105df36ab24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BAROSTIM NEO
• Version Model Number: 1036
• Catalog Number: 100063-212
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7634167457
• Email: acrouse@cvrx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859144004463 [Primary]

FDA Product Code

• DSR: Stimulator, Carotid Sinus Nerve

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-30
• Device Publish Date: 2019-08-22

On-Brand Devices [BAROSTIM NEO]

• 00859144004470: BAROSTIM NEO Model 1037 Carotid Sinus Lead Kit
• 00859144004463: BAROSTIM NEO Model 1036 Carotid Sinus Lead Kit (US Commercial)
• 00859144004432: BAROSTIM NEO Model 2102 Implantable Pulse Generator (US Commercial)