FDA UDI
In Commercial Distribution
🇺🇸 United States
Howard Leight by Honeywell
DI: 00033552016847
·
Model: AquaSeal
·
SPERIAN HEARING PROTECTION, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Howard Leight by Honeywell
- Primary DI
- 00033552016847
- Version / Model
- AquaSeal
- Catalog Number
- R-01684
- Company Name
- SPERIAN HEARING PROTECTION, LLC
- Labeler DUNS
- 014982953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-11
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 61886c91-8bb4-40da-95fe-35dd11eb0fe1
Device Description
AquaSeal Water-Blocking Reusable Earplugs with Carrying Case, 2-Pairs Howard Leight by Honeywell AquaSeal Water-Blocking Reusable Earplugs are specially designed to help prevent swimmer's ear. Using a triple flange design, these earplugs create a series of low-pressure air pocket seals inside your ear canal. The result is a comfortable, water-resistant earplug that's soft on your inner ear. Insertion and removal are easy thanks to the convenient outer handle. This package comes with a convenient carrying case for easy storage in the boat, on the dock, or in your pocket. 2 pairs of earplugs per pack
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| EWD | Protector, Hearing (Insert) | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35024 | Earplugs, single-use | A device, usually used as a pair, made of rubber or pliable plastic/silicone material intended to be inserted into the outer ear canal for protection against excessive noise levels or water entering the ears when swimming/bathing. This device may be premoulded (preformed) or mouldable. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00033552016847 | GS1 |