Identity
- Trade Name
- VITARIA™ Patient Essentials, Model 7220 FDA UDI
- Generic Name
- Active implantable device control magnet FDA UDI
- Device Name
- Patient Magnet FDA UDI
- Model / Reference
- 7220 FDA UDI
- Description
- Patient Magnet FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05425025750313 FDA UDI
- 510(k) Number
- K092364 FDA UDI
- FDA Product Code
- DTG FDA UDI
- GMDN Term
- Active implantable device control magnet FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Active implantable device control magnet
VITARIA™ Patient Essentials, Model 7220 by LivaNova USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Active implantable device control magnet.
- Magnet — Neuropace, Inc. · Class III
- Senza — Nevro Corporation · Class III
- BIOTRONIK — BIOTRONIK SE & Co. KG · Class III
- ReActiv8 Magnet — MAINSTAY MEDICAL LIMITED · Class III
- Algovita® — Greatbatch Ltd · Class III
- Axium™ — ST. JUDE MEDICAL, INC. · Class III
- Cyberonics® Patient Magnet — LivaNova USA, Inc. · Class I
Cleared under the same submission
K092364 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- LivaNova USA, Inc.
Sources (1)
- FDA UDI bd4434e3-0ac2-47fb-abf4-99ba6c962739 36 fields · synced Jun 8, 2026