FDA UDI
In Commercial Distribution
🇺🇸 United States
BAROSTIM Programmer
DI: 00859144004449
·
Model: 9010
·
CVRX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BAROSTIM Programmer
- Primary DI
- 00859144004449
- Version / Model
- 9010
- Catalog Number
- 100055-202
- Company Name
- CVRX, INC.
- Labeler DUNS
- 052373680
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-22
- Public Version
- 1
- Public Version Date
- 2019-08-30
- Public Version Status
- New
- Public Device Record Key
- 2a3c221d-193e-411f-aa8c-97764eebd4ad
Device Description
Model 9010 Programmer System (US Commercial)
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 | 00859144004449 | GS1 |
Customer Contacts
- Phone
- 7634167457
- [email protected]