AccessGUDID - DEVICE: E-A-RLINK™ (00080529510068)

GUDID

Device Identifier (DI) Information

Brand Name: E-A-RLINK™
Version or Model: 420-2028
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 420-2028
Company Name: 3M COMPANY

Primary DI Number: 00080529510068
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 24
Labeler D-U-N-S® Number*: 078763316 *Terms of Use

Device Description: 3M(TM) E-A-RLINK(TM) 3C Foam Eartip large size, yellow, with black tube 420-2028-5, 24/case

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?
62133	Audiometric ear tip	A luminal device intended to be connected to the distal end of an audiometric sound delivery tube and inserted into the ear canal, to allow test sounds to be delivered to the ear in isolation from background noise. It is designed to create a seal inside the ear canal whilst allowing the sound tube to pass through the lumen. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ETT	CUSHION, EARPHONE (FOR AUDIOMETRIC TESTING)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 6cb48c08-4ce8-4363-a890-fcfcfeffe4c0
Public Version Date: June 30, 2025
Public Version Number: 3
DI Record Publish Date: September 24, 2016