AccessGUDID - DEVICE: Relivion MG App (07290018393147)

GUDID

Device Identifier (DI) Information

Brand Name: Relivion MG App
Version or Model: RLV-PMI-102
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEUROLIEF LTD

Primary DI Number: 07290018393147
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600484465 *Terms of Use

Device Description: An application software program intended to extract, process, and store non-clinical processing data (e.g., log of equipment usage, equipment status) from medical equipment to assist process management. It is not intended for control of equipment

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	No
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?
60065	Configurable electronic form web-based application software	An application software program designed as an Internet-based information system intended to replace paper forms by electronically collecting and recording all types of patient clinical information, investigation results, and treatment data. It is a generic system which can be used in healthcare by configuration of workflows, metadata, and data lifecycles; and by integration into electronic medical record (EMR) systems using standard protocols. The electronic forms are intended to provide predefined workflow, input, search, and display functionalities, typically to manage a particular treatment or condition [e.g., hyposensitization (allergy desensitization), cleft lip].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PCC	Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212106	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b4e04d98-ae2d-4dd3-aa0d-2965c5e4de53
Public Version Date: July 25, 2023
Public Version Number: 2
DI Record Publish Date: December 19, 2021