Identity
- Trade Name
- Shelco Filtration System FDA UDI
- Generic Name
- Particulate water purification filter FDA UDI
- Device Name
- Pre-RO 1" Shelco Housing Assembly, Holds (4) 20” Filters, 1-Micron, With Bypass Valves FDA UDI
- Model / Reference
- A-PT-5061-100 FDA UDI
- Description
- Pre-RO 1" Shelco Housing Assembly, Holds (4) 20” Filters, 1-Micron, With Bypass Valves FDA UDI
Identifiers
- Primary DI / UDI-DI
- B297APT50611000 FDA UDI
- FDA Product Code
- FIP FDA UDI
- GMDN Term
- Particulate water purification filter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5665 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Particulate water purification filter
Shelco Filtration System by Speciality Water Technology — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Speciality Water Technology
Sources (1)
- FDA UDI 97f92b89-bc61-466c-8e63-e43b6892046d 34 fields · synced Jun 8, 2026