Duns Number:002345767
Device Description: Lumen 155i Behind-the-Ear Air-Conduction Hearing Aid, Metallic Black
Catalog Number
93423-002
Brand Name
Hearing Help Express
Version/Model Number
Apollo 6670
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
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
ESD
Product Code Name
Hearing Aid, Air Conduction
Public Device Record Key
aec1d4df-6d19-4cda-b2bb-ef59abf674fd
Public Version Date
October 06, 2020
Public Version Number
2
DI Record Publish Date
August 28, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 64 |