AccessGUDID - DEVICE: AIM™ Insert Earphone (00840094454675)

GUDID

Device Identifier (DI) Information

Brand Name: AIM™ Insert Earphone
Version or Model: CI-6129
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Advanced Bionics, LLC

Primary DI Number: 00840094454675
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 803906382 *Terms of Use
Previous DI: 07630016864636

Device Description: No description.

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):	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?
62901	Cochlear implant/auditory brainstem implant sound processor speaker	A small device designed to be attached to the sound processor of a cochlear implant or auditory brainstem implant system and extended into the external ear canal to function as a speaker providing amplified acoustic low-frequency sound to the eardrum, as a conjunct to the electrical input to the implant. It is intended for patients with improvable low-frequency hearing and is typically made of synthetic polymer materials with metallic components. This is a single-patient, reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCM	Implant, cochlear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P960058	133

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 -20 and 55 Degrees Celsius
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3d0e79b0-5a95-4512-ba81-201acbe9e568
Public Version Date: December 19, 2022
Public Version Number: 1
DI Record Publish Date: December 09, 2022