AccessGUDID - DEVICE: Echo-Screen Hearing Screening Supplies (00382830051231)

GUDID

Device Identifier (DI) Information

Brand Name: Echo-Screen Hearing Screening Supplies
Version or Model: Echo-PAK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1630-25-US
Company Name: NATUS MEDICAL INCORPORATED

Primary DI Number: 00382830051231
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 962519208 *Terms of Use

Device Description: 25 sets of Echo-Screen II Ear Couplers and 25 sets of 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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41213	Ear simulator, acoustic coupler	A cavity, of predetermined shape and volume, used for the calibration of earphones in conjunction with a calibrated microphone adapted to measure the sound pressure developed within the cavity. Acoustic couplers have cavities varying in size according to their use, e.g., the 6cc coupler is used with supra-aural earphones while the 2cc coupler is used for hearing aid insert earphones.	Active	false
11440	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.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K013977	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: 7cab5d27-03b0-43ec-8940-746a25afd6c1
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 06, 2017