FDA UDI
In Commercial Distribution
🇺🇸 United States
PRETREAT, 1", 208V, CPVC, SHORT, AC
DI: PR0023
·
Model: WM-PRE-4103-CSA
·
BETTER WATER, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PRETREAT, 1", 208V, CPVC, SHORT, AC
- Primary DI
- PR0023
- Version / Model
- WM-PRE-4103-CSA
- Catalog Number
- WM-PRE-4103-CSA
- Company Name
- BETTER WATER, LLC
- Labeler DUNS
- 055252159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-13
- Public Version
- 1
- Public Version Date
- 2024-11-21
- Public Version Status
- New
- Public Device Record Key
- 807ed38b-6f37-4fdc-b6bb-73396fbfc007
Device Description
Pretreatment rack with control box and blend valve. 1" piping, CPVC, 208V AC, short version.
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 |
|---|---|---|---|---|
| 44344 | Combination water purification system | An assembly of electrically-powered devices, or stand-alone device, designed to remove unwanted chemical, particulate, and/or biological contaminants from water. This system purifies water using a combination of methods including particulate filtration, chemical disinfection, deionization, reverse osmosis, and/or ultraviolet light. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | PR0023 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K920186 | 000 |