FDA UDI
In Commercial Distribution
🇺🇸 United States
Zeolite Filter Tank
DI: B297KAMT7H532050
·
Model: K-A-MT-7H53-205
·
SPECIALITY WATER TECHNOLOGY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Zeolite Filter Tank
- Primary DI
- B297KAMT7H532050
- Version / Model
- K-A-MT-7H53-205
- Company Name
- SPECIALITY WATER TECHNOLOGY
- Labeler DUNS
- 032528935
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-28
- Public Version
- 1
- Public Version Date
- 2020-03-09
- Public Version Status
- New
- Public Device Record Key
- adb0778f-b5e0-43d4-bcac-8d30ebc38687
Device Description
Zeolite Filter Tank (5 cu ft), 18" x 65", Fleck SXT 2815, 25 DLFC
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 |
|---|---|---|---|---|
| 35431 | Charcoal water purification filter | A device containing charcoal designed to filter primarily soluble organic components from flowing water. It is typically filled with activated carbon to adsorb low-molecular weight organics such as chloramines, a substance that is frequently used in tap water sources as a bactericidal agent. The device is frequently used to filter tap water intended for haemodialysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B297KAMT7H532050 | HIBCC |
Customer Contacts
- Phone
- 615-654-4441
- [email protected]