FDA UDI
In Commercial Distribution
🇺🇸 United States
EarPro
DI: 05065006332208
·
Model: 20ml
·
Liquidpro US
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EarPro
- Primary DI
- 05065006332208
- Version / Model
- 20ml
- Catalog Number
- 20
- Company Name
- Liquidpro US
- Labeler DUNS
- 048485021
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-28
- Public Version
- 2
- Public Version Date
- 2024-04-03
- Public Version Status
- Update
- Public Device Record Key
- 42ff0942-a714-4af6-aca1-244e1340f68b
Device Description
EarPro is a blend of medical grade mineral oil and premium organic oregano oil to combat problems related to water exposure in ears EarPro acts as a protective layer.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NEC | Bandage, Liquid, Skin Protectant | General Hospital | 880.5090 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46259 | Moisture/lubrication otic oil | An oil-based substance intended to be applied to the external auditory canal of the ear to provide moisture and/or lubrication typically to facilitate softening and/or removal of ear wax, removal of impurities, barrier to external water, and/or loosening of encrustations; it may in addition have non-pharmaceutical antimicrobial and/or anti-inflammatory properties (e.g., oregano oil). It is typically available as a liquid to be applied as a spray or drops, and is normally available for use in the home by a layperson. After application, this device cannot be reused. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05065006332208 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 39 – 113 Degrees Fahrenheit