AccessGUDID - DEVICE: VNS Therapy® Programming Wand Model 2000 (05425025750177)

GUDID

Device Identifier (DI) Information

Brand Name: VNS Therapy® Programming Wand Model 2000
Version or Model: 2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LIVANOVA USA, INC.

Primary DI Number: 05425025750177
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 194568978 *Terms of Use

Device Description: Programming Wand

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
44077	Vagus nerve electrical stimulation system programmer	A device intended to be used to change, noninvasively, one or more of the operating parameters (the programs) of an implanted stimulator used for vagus nerve stimulation (VNS). It is able to read stored parameters in the implanted device, providing historic and/or current information regarding device performance. The device is typically an electronic wand with a communication antenna that connects to the port of a personal computer (PC) with dedicated software. The PC will then drive the electronics of the wand to communicate with the implanted stimulation system.	Active	false

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	210

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -22 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2d5d3e1b-2921-4d34-95f5-ab0269ec8364
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 06, 2017