FDA UDI
In Commercial Distribution
🇺🇸 United States
AmeriWater 0077-0010 Ozone Disinfection System
DI: 00817927020086
·
Model: 0077-0010
·
AMERIWATER, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AmeriWater 0077-0010 Ozone Disinfection System
- Primary DI
- 00817927020086
- Version / Model
- 0077-0010
- Company Name
- AMERIWATER, LLC
- Labeler DUNS
- 836758342
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-06
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- ae0df625-c029-47fd-baa3-a1ee61938abd
Device Description
Portable Ozone Disinfection System for water storage tanks and bicarb systems.
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
- No
- 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 |
|---|---|---|---|---|
| FIN | Tank, Holding, Dialysis | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46087 | Ozone generator, portable | A conveniently moveable, mains electricity (AC-powered) device used to create and deliver ozone (O3) - also known as trioxygen. It typically produces a high electrical voltage between electrodes, to convert bottled oxygen (O2) into O3 when passed through the electrode gap. It usually includes measuring devices to determine output O3 concentration, and a mechanism to destroy internally the unused ozone; it is typically used at the site of application because it is not possible to store ozone. O3 has been used for various purposes in the laboratory, to disinfect/purify air and water, and in some clinical treatment of diseases. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817927020086 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141213 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 70 | Pound | |
| Depth | 24 | Inch | |
| Width | 15 | Inch | |
| Height | 35 | Inch |