FDA UDI
In Commercial Distribution
🇺🇸 United States
ULTRAFILTER, 5UF, VERTICAL
DI: UF0004
·
Model: EQASSYUF42500
·
BETTER WATER, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ULTRAFILTER, 5UF, VERTICAL
- Primary DI
- UF0004
- Version / Model
- EQASSYUF42500
- Catalog Number
- EQASSYUF42500
- Company Name
- BETTER WATER, LLC
- Labeler DUNS
- 055252159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-13
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 814a493a-354c-4086-ac9e-c4922f99f043
Device Description
Ultra-filter for water purification for dialysis applications. 5 ultra-filter membranes, vertical orientation.
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
- No
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | UF0004 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K920186 | 000 |