Duns Number:539177681
Device Description: Lexie Lumen self-fitting Beige hearing aid - Duo
Catalog Number
Lumen 155
Brand Name
Lexie Hearing
Version/Model Number
Lumen Duo Beige
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OSM
Product Code Name
Hearing Aid, Air Conduction With Wireless Technology
Public Device Record Key
2a648f93-fd20-4753-87e3-da1595745a1a
Public Version Date
October 03, 2022
Public Version Number
1
DI Record Publish Date
September 23, 2022
Package DI Number
10860003469801
Quantity per Package
36
Contains DI Package
00860003469804
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |