VITARIA™ Patient Essentials, Model 7220

GUDID 05425025750313

Patient Magnet

LIVANOVA USA, INC.

Implantable stimulator control magnet
Primary Device ID05425025750313
NIH Device Record Keybd4434e3-0ac2-47fb-abf4-99ba6c962739
Commercial Distribution StatusIn Commercial Distribution
Brand NameVITARIA™ Patient Essentials, Model 7220
Version Model Number7220
Company DUNS194568978
Company NameLIVANOVA USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105425025750313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTGMagnet, Test, Pacemaker

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-07
Device Publish Date2020-06-29

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00803622158049 - Perfusion Pack2024-11-13
10803622157520 - Perfusion Pack2024-11-05
00803622157981 - Perfusion Pack2024-11-05
10803622158008 - Perfusion Pack2024-11-05
00803622158018 - Perfusion Pack2024-11-05

Trademark Results [VITARIA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VITARIA
VITARIA
86271385 4818939 Live/Registered
LIVANOVA USA, INC.
2014-05-05
VITARIA
VITARIA
86021936 4809103 Live/Registered
Cyberonics, Inc.
2013-07-29

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