FDA UDI
In Commercial Distribution
🇺🇸 United States
Dual Big Blue Sediment Filter
DI: B297KAPT50540
·
Model: K-A-PT-5054
·
SPECIALITY WATER TECHNOLOGY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Dual Big Blue Sediment Filter
- Primary DI
- B297KAPT50540
- Version / Model
- K-A-PT-5054
- Company Name
- SPECIALITY WATER TECHNOLOGY
- Labeler DUNS
- 032528935
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 30dc0fbe-ad9a-4012-a0d4-68a7c20b12df
Device Description
1 1/2” Dual Bank, Big Blue Filter Assembly with By-Pass Valves, Gauges and Sample Ports
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
- No
- 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 | B297KAPT50540 | HIBCC |
Customer Contacts
- Phone
- 615-654-4441
- [email protected]