FDA UDI
In Commercial Distribution
🇺🇸 United States
VNS Therapy® Pulse Duo Model 102R Generator
DI: 05425025750023
·
Model: 102R
·
LIVANOVA USA, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VNS Therapy® Pulse Duo Model 102R Generator
- Primary DI
- 05425025750023
- Version / Model
- 102R
- Company Name
- LIVANOVA USA, INC.
- Labeler DUNS
- 194568978
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-17
- Public Version
- 4
- Public Version Date
- 2020-03-05
- Public Version Status
- Update
- Public Device Record Key
- 28ab844c-d967-40bb-8ef5-b1b29e5f7d58
Device Description
Implantable Pulse Generator
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
- Yes
- MRI Safety
- MR Conditional
- 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 |
|---|---|---|---|---|
| MUZ | Stimulator, Autonomic Nerve, Implanted (Depression) | Unknown | 3 | |
| LYJ | Stimulator, Autonomic Nerve, Implanted For Epilepsy | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34210 | Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system | An assembly of battery-powered devices intended to apply periodic electrical stimuli to the vagus nerve to help control seizures and/or to help treat psychiatric disorder symptoms (e.g., depression). The vagus nerve stimulation (VNS) is provided through an implantable pulse generator, typically placed in the anterior chest wall, and leads that run subcutaneously to where their electrodes are implanted around the left vagus nerve. The system may be programmed externally following implantation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05425025750023 | GS1 |
Customer Contacts
- Phone
- 1 (866) 882-8804
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P970003 | 047 |
| P970003 | 158 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 55 Degrees Celsius