FDA UDI
In Commercial Distribution
🇺🇸 United States
AmeriWater MROS
DI: 00817927020000
·
Model: MROS
·
AMERIWATER, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AmeriWater MROS
- Primary DI
- 00817927020000
- Version / Model
- MROS
- Company Name
- AMERIWATER, LLC
- Labeler DUNS
- 836758342
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-05
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 8c0a38d8-e28a-4818-ad35-655d07cf0fb7
Device Description
MROS, Single Patient Portable RO, 730 GPD, 115V
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- Yes
- Sterilization Methods
- ["Peracetic Acid", "High-level Disinfectant"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FIP | Subsystem, Water Purification | Gastroenterology, Urology | 876.5665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14437 | Reverse-osmosis water purification system | An assembly of devices designed to remove unwanted contaminants (bacteria, viruses, chemicals, dissolved substances) from water using osmotic pressure applied to one side of a selective membrane. The system removes ions, large molecules (e.g. proteins, glucose, urea, salts) and other particles from solution by forcing water at high pressure through a membrane containing pores just big enough (e.g., 0.0005 microns) to permit passage of small molecules and water, whilst the contaminants are flushed to waste. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817927020000 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111740 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 135 | Pound | |
| Depth | 24 | Inch | |
| Width | 17 | Inch | |
| Height | 47 | Inch |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 41 – 104 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 104 Degrees Fahrenheit