FDA.reportPublic FDA data

VITARIA™ Patient Essentials, Model 7220

Primary DI
05425025750313
Brand
VITARIA™ Patient Essentials, Model 7220
Company
LIVANOVA USA, INC.
Model
7220
Device description
Patient Magnet
Published
2020-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTGMagnet, Test, Pacemaker

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTGMagnet, Test, PacemakerCardiovascular1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092364000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092364000MODEL 220 PATIENT MAGNETCyberonics, Inc.2009-11-03DTG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05425025750313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05425025750313054250257503135425025750313

GMDN Terms#

Term, Definition table
TermDefinition
Implantable stimulator control magnetA hand-operated, non-sterile, magnetic device designed to be used by a patient to switch an implanted stimulator (e.g., a neurostimulator that can be controlled by a strong external magnetic force) on and off. It typically consists of a small portable magnet (e.g., strontium ferrite) coated with an epoxy that can be carried in the pocket or a handbag (purse) of a patient for convenient access. It is placed by the patient against the skin directly over the site of the implanted stimulator and turned as prescribed by the manufacturer to affect the stimulator. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 (866) 882-8804ClinicalTechnicalServices@cyberonics.com

Regulatory Flags#

DUNS number
194568978
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00803622164965Perfusion PackPerfusion Pack2026-10-22
00803622164804Perfusion PackPerfusion Pack2026-10-19
00803622164811Perfusion PackPerfusion Pack2026-10-19
00803622164842Perfusion PackPerfusion Pack2026-10-19
00803622164910Perfusion PackPerfusion Pack2026-10-19
00803622164927Perfusion PackPerfusion Pack2026-10-19
00803622164934Perfusion PackPerfusion Pack2026-10-19
00803622164941Perfusion PackPerfusion Pack2026-10-19
00803622164958Perfusion PackPerfusion Pack2026-10-19
00803622164989Perfusion PackPerfusion Pack2026-10-19
00803622164996Perfusion PackPerfusion Pack2026-10-19
00803622165047Perfusion PackPerfusion Pack2026-10-19
00803622165054Perfusion PackPerfusion Pack2026-10-19
00803622103001Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103018Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103025Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103032Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103049Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103056Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103063Cardioplegia cannulaAR-xxxxx2015-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05414734507004NAST. JUDE MEDICAL, INC.DTG2025-04-30
08031527019956MagnetMICROPORT CRM SRLDTG2021-09-23
06973102450018JENITEKSUZHOU JENITEK MEDICAL CO.,LTD.DTG2020-07-06
20613994647812NAMEDTRONIC, INC.DTG2014-10-27
05425025750252Cyberonics® Patient MagnetLIVANOVA USA, INC.DTG2014-09-17