FDA UDI
In Commercial Distribution
🇺🇸 United States
Lucid®
DI: 00810068831443
·
Model: Enrich Pro BTE
·
HEARING LAB TECHNOLOGY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lucid®
- Primary DI
- 00810068831443
- Version / Model
- Enrich Pro BTE
- Catalog Number
- 10082
- Company Name
- HEARING LAB TECHNOLOGY, LLC
- Labeler DUNS
- 827693503
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-31
- Public Version
- 1
- Public Version Date
- 2022-11-08
- Public Version Status
- New
- Public Device Record Key
- b21cb9d9-dec5-4009-98e7-3b0c67697da1
Device Description
Enrich Pro BTE OTC
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QUF | Hearing Aid, Air-Conduction, Over the Counter | Ear, Nose, Throat | 874.3300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62260 | Air-conduction hearing aid acoustic tube | A small tubular detachable device designed to conduct sound waves from an air-conduction hearing aid [e.g., behind-the-ear (BTE)] to an earmould to convey acoustic output to the eardrum. It is made of soft synthetic polymer materials. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810068831443 | GS1 |
Customer Contacts
- Phone
- +1(866)202-2527
- [email protected]