AccessGUDID - DEVICE: VNS Therapy® Pulse Duo Model 102R Generator (05425025750023)

GUDID

Device Identifier (DI) Information

Brand Name: VNS Therapy® Pulse Duo Model 102R Generator
Version or Model: 102R
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LIVANOVA USA, INC.

Primary DI Number: 05425025750023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 194568978 *Terms of Use

Device Description: Implantable Pulse Generator

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34210	Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system	An assembly of battery-powered devices intended to apply periodic electrical stimuli to the vagus nerve to help control seizures and/or to help treat psychiatric disorder symptoms (e.g., depression). The vagus nerve stimulation (VNS) is provided through an implantable pulse generator, typically placed in the anterior chest wall, and leads that run subcutaneously to where their electrodes are implanted around the left vagus nerve. The system may be programmed externally following implantation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MUZ	Stimulator, Autonomic Nerve, Implanted (Depression)
LYJ	Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P970003	047
P970003	158

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 28ab844c-d967-40bb-8ef5-b1b29e5f7d58
Public Version Date: March 05, 2020
Public Version Number: 4
DI Record Publish Date: September 17, 2014