AccessGUDID - DEVICE: VNS Therapy® PerenniaFLEX® Model 304 Lead (05425025750139)

GUDID

Device Identifier (DI) Information

Brand Name: VNS Therapy® PerenniaFLEX® Model 304 Lead
Version or Model: 304-20
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LIVANOVA USA, INC.

Primary DI Number: 05425025750139
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 194568978 *Terms of Use

Device Description: Implantable Lead

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?
44041	Vagus nerve electrical stimulation system lead	An implantable wire, insulated with non-conductive material except at its electrode(s), intended to be used to make an electrical connection between a pulse generator and the vagus nerve for vagus nerve stimulation (VNS).	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	100

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
Outer Diameter: 2.0 Millimeter

Device Record Status

Public Device Record Key: 49bd6777-9579-4d84-8095-302e5f8c5d82
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 17, 2014