VITARIA™ Patient Essentials, Model 7220
GUDID 05425025750313
Patient Magnet
LIVANOVA USA, INC.
Implantable stimulator control magnet Implantable stimulator control magnet Implantable stimulator control magnet Implantable stimulator control magnet Implantable stimulator control magnet Implantable stimulator control magnet Implantable stimulator control magnet Implantable stimulator control magnet Implantable stimulator control magnet Active implantable device control magnet Active implantable device control magnet Active implantable device control magnet Active implantable device control magnet Active implantable device control magnet Active implantable device control magnet Active implantable device control magnet Active implantable device control magnet Active implantable device control magnet Active implantable device control magnet Active implantable device control magnet Active implantable device control magnet Active implantable device control magnet Active implantable device control magnet Active implantable device control magnet Active implantable device control magnet| Primary Device ID | 05425025750313 |
| NIH Device Record Key | bd4434e3-0ac2-47fb-abf4-99ba6c962739 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VITARIA™ Patient Essentials, Model 7220 |
| Version Model Number | 7220 |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05425025750313 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092364
FDA Product Code
| DTG | Magnet, Test, Pacemaker |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-07 |
| Device Publish Date | 2020-06-29 |
Devices Manufactured by LIVANOVA USA, INC.
| 10803622156509 - Cardioplegia Pack | 2024-04-23 |
| 10803622156516 - Cardioplegia Pack | 2024-04-23 |
| 00803622156526 - Perfusion Pack | 2024-04-23 |
| 00803622156533 - Perfusion Pack | 2024-04-23 |
| 00803622156540 - Perfusion Pack | 2024-04-23 |
| 10803622156554 - Perfusion Pack | 2024-04-23 |
| 10803622156561 - Perfusion Pack | 2024-04-23 |
| 10803622156592 - Cardioplegia Pack | 2024-04-23 |
Trademark Results [VITARIA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VITARIA 86271385 4818939 Live/Registered |
LIVANOVA USA, INC. 2014-05-05 |
 VITARIA 86021936 4809103 Live/Registered |
Cyberonics, Inc. 2013-07-29 |
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