VNS Therapy® Model 250 v8.1 Programming Software
GUDID 05425025750191
Programming Software
LIVANOVA USA, INC.
Vagus nerve electrical stimulation system programmer| Primary Device ID | 05425025750191 |
| NIH Device Record Key | f12ed5c2-c455-4626-8f7a-1c321250c7f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VNS Therapy® Model 250 v8.1 Programming Software |
| Version Model Number | 250 v8.1 (X5) |
| Company DUNS | 194568978 |
| Company Name | LIVANOVA USA, 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1 (866) 882-8804 |
| ClinicalTechnicalServices@cybe |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05425025750191 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P970003
FDA Product Code
| MUZ | Stimulator, Autonomic Nerve, Implanted (Depression) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-17 |
Devices Manufactured by LIVANOVA USA, INC.
| 10803622156394 - Perfusion Pack | 2024-04-17 |
| 10803622156448 - Perfusion Pack | 2024-04-17 |
| 10803622156455 - Perfusion Pack | 2024-04-17 |
| 00803622156472 - Perfusion Pack | 2024-04-17 |
| 10803622156486 - Perfusion Pack | 2024-04-17 |
| 00803622156496 - Perfusion Pack | 2024-04-17 |
| 10803622156424 - Perfusion Pack | 2024-04-12 |
| 10803622156431 - Perfusion Pack | 2024-04-12 |
Trademark Results [VNS Therapy]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VNS THERAPY 78939216 3607760 Live/Registered |
LIVANOVA USA, INC. 2006-07-27 |
 VNS THERAPY 78939212 3607759 Dead/Cancelled |
LIVANOVA USA, INC. 2006-07-27 |
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