AccessGUDID - DEVICE: Bio-logic (00382830008365)

GUDID

Device Identifier (DI) Information

Brand Name: Bio-logic
Version or Model: Disposable Snap Electrodes
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 101600; 101603
Company Name: NATUS MEDICAL INCORPORATED

Primary DI Number: 00382830008365
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962519208 *Terms of Use

Device Description: Disposable Snap Electrodes

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Analytical scalp electrode, single-use	A noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

GMDN Preferred Term Name

GMDN Definition

Analytical scalp electrode, single-use

A noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

FDA Product Code

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Product Code	Product Code Name
EWO	Audiometer
GWJ	Stimulator, Auditory, Evoked Response

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031009	000
K073626	000
K083371	000
K112247	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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Length: 1.31 Inch
Width: 0.88 Inch

Device Record Status

Public Device Record Key: 46e9cc32-c0a5-4552-a52c-6037ca92a259
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 30, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00382830001427	300	00382830008365	2017-08-01	Not in Commercial Distribution	101603
00382830001410	60	00382830008365	2017-08-01	Not in Commercial Distribution	101600
00382830054928	100	00382830008365		In Commercial Distribution	101603
00382830054911	20	00382830008365		In Commercial Distribution	101600