FDA UDI
Not in Commercial Distribution
🇺🇸 United States
HydraGuard 10” UltraFilter - Flushable
DI: 00866318000336
·
Model: 70-0111F
·
NEPHROS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- HydraGuard 10” UltraFilter - Flushable
- Primary DI
- 00866318000336
- Version / Model
- 70-0111F
- Company Name
- NEPHROS, INC.
- Labeler DUNS
- 120664557
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-18
- Public Version
- 5
- Public Version Date
- 2021-09-17
- Public Version Status
- Update
- Public Device Record Key
- 9ad709d2-0c0b-49af-bbbd-1d5cd8a76719
- Distribution End Date
- 2017-12-18
Device Description
The HydraGuard 10” UltraFilter - Fin is intended to be used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for washing and drinking, the filter aids in infection control. The filter produces water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands Contraindications: Medical: The filter is not intended to provide water that can be used as a substitute for USP sterile water.
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
- 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 |
|---|---|---|---|---|
| NHV | System, Water Purification, General Medical Use | Gastroenterology, Urology | 876.5665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35433 | Particulate water purification filter | A device designed to remove sediment and other suspended particles from flowing water by creating a mechanical barrier to elements larger than a specified size (e.g., 5 to 10 microns/micrometres); it is often made of polypropylene filaments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20866318000330 | GS1 | Carton Box | 30 | Not in Commercial Distribution | 2017-12-18 |
| Package | 10866318000333 | GS1 | Filter Box | 1 | Not in Commercial Distribution | 2017-12-18 |
| Primary | 00866318000336 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161467 | 000 |