Primary Device ID | 00846430006027 |
NIH Device Record Key | df21f3d0-22b2-4108-8f55-e3c48a6b1ea6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | LucidHearing |
Version Model Number | BHA-Tala-MFI-OTC |
Company DUNS | 115380859 |
Company Name | ETYMOTIC RESEARCH, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | (800) 492-4515 |
customerservice@budgethearingaids.com | |
Phone | (800) 492-4515 |
customerservice@budgethearingaids.com | |
Phone | (800) 492-4515 |
customerservice@budgethearingaids.com | |
Phone | (800) 492-4515 |
customerservice@budgethearingaids.com | |
Phone | (800) 492-4515 |
customerservice@budgethearingaids.com | |
Phone | (800) 492-4515 |
customerservice@budgethearingaids.com | |
Phone | (800) 492-4515 |
customerservice@budgethearingaids.com | |
Phone | (800) 492-4515 |
customerservice@budgethearingaids.com | |
Phone | (800) 492-4515 |
customerservice@budgethearingaids.com | |
Phone | (800) 492-4515 |
customerservice@budgethearingaids.com | |
Phone | (800) 492-4515 |
customerservice@budgethearingaids.com | |
Phone | (800) 492-4515 |
customerservice@budgethearingaids.com | |
Phone | (800) 492-4515 |
customerservice@budgethearingaids.com | |
Phone | (800) 492-4515 |
customerservice@budgethearingaids.com | |
Phone | (800) 492-4515 |
customerservice@budgethearingaids.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00846430006027 [Primary] |
QUG | Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-04-17 |
Device Publish Date | 2025-04-09 |
00846430006034 | BHA-Tala-Android-OTC 20138-BHA |
00846430006027 | BHA-Tala-MFI-OTC 20128-BHA |