NA

Basic Information

• Brand Name: NA
• Primary DI: 00859144004203
• Version / Model: 5010
• Catalog Number: 100056-301
• Company Name: CVRX, INC.
• Labeler DUNS: 052373680
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-01-21
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: fac3f0be-cb43-44c9-8714-9013818916a6

Device Description

Carotid Sinus Lead Repair Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DSR	Stimulator, Carotid Sinus Nerve	Cardiovascular	870.3850	3

GMDN Terms

Code	Name	Definition	Implantable	Status
35369	Baroreceptor electrical stimulation system	An 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).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859144004203	GS1