VNS Therapy® SenTiva Duo™ Model 1000-D Generator

GUDID 05425025750528

Implantable Pulse Generator

LIVANOVA USA, INC.

Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Primary Device ID05425025750528
NIH Device Record Keyd71f4ba1-529e-40de-bf27-be38a5368a8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameVNS Therapy® SenTiva Duo™ Model 1000-D Generator
Version Model Number1000-D
Company DUNS194568978
Company NameLIVANOVA USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
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@livanova.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@livanova.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@livanova.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@livanova.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@livanova.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@livanova.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@livanova.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@livanova.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@livanova.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@livanova.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@livanova.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@livanova.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@livanova.com
Phone1 (866) 882-8804
EmailClinicalTechnicalServices@livanova.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

Device Identifiers

Device Issuing AgencyDevice ID
GS105425025750528 [Primary]
GS105425025750528 [Primary]
GS105425025750528 [Primary]
GS105425025750528 [Primary]
GS105425025750528 [Primary]
GS105425025750528 [Primary]
GS105425025750528 [Primary]
GS105425025750528 [Primary]
GS105425025750528 [Primary]
GS105425025750528 [Primary]
GS105425025750528 [Primary]
GS105425025750528 [Primary]
GS105425025750528 [Primary]
GS105425025750528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUZStimulator, Autonomic Nerve, Implanted (Depression)
MUZStimulator, Autonomic Nerve, Implanted (Depression)
MUZStimulator, Autonomic Nerve, Implanted (Depression)
MUZStimulator, Autonomic Nerve, Implanted (Depression)
MUZStimulator, Autonomic Nerve, Implanted (Depression)
MUZStimulator, Autonomic Nerve, Implanted (Depression)
MUZStimulator, Autonomic Nerve, Implanted (Depression)
MUZStimulator, Autonomic Nerve, Implanted (Depression)
MUZStimulator, Autonomic Nerve, Implanted (Depression)
MUZStimulator, Autonomic Nerve, Implanted (Depression)
MUZStimulator, Autonomic Nerve, Implanted (Depression)
MUZStimulator, Autonomic Nerve, Implanted (Depression)
MUZStimulator, Autonomic Nerve, Implanted (Depression)
MUZStimulator, Autonomic Nerve, Implanted (Depression)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-30
Device Publish Date2020-07-22

Devices Manufactured by LIVANOVA USA, INC.

05425025750528 - VNS Therapy® SenTiva Duo™ Model 1000-D Generator2020-07-30Implantable Pulse Generator
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00803622146701 - Perfusion Pack2020-07-28
00803622146718 - Perfusion Pack2020-07-28
10803622146722 - Perfusion Pack2020-07-22
00803622146565 - Perfusion Pack2020-07-08
10803622146586 - Perfusion Pack2020-07-08
05425025750313 - VITARIA™ Patient Essentials, Model 72202020-07-07 Patient Magnet

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