BAROSTIM Lead Repair Kit 100056-202

GUDID 00859144004456

Model 5010 Carotid Sinus Lead Repair Kit (US Commercial)

CVRX, INC.

Baroreceptor electrical stimulation system

• Primary Device ID: 00859144004456
• NIH Device Record Key: d06cd191-f779-41c5-a160-a30f61fab3d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BAROSTIM Lead Repair Kit
• Version Model Number: 5010
• Catalog Number: 100056-202
• 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	00859144004456 [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

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: 2019-08-30Model 5010 Carotid Sinus Lead Repair Kit (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