Identity
- Trade Name
- Pall QPoint® Filter Capsule FDA UDI
- Generic Name
- Microbial water purification filter, non-sterilizable FDA UDI
- Device Name
- Pall QPoint® Filter Capsule, Water Filter Capsule for Shower FDA UDI
- Model / Reference
- QR22A FDA UDI
- Description
- Pall QPoint® Filter Capsule, Water Filter Capsule for Shower FDA UDI
Identifiers
- Catalog Number
- QR22A FDA UDI
- Primary DI / UDI-DI
- 05034480315533 FDA UDI
- 510(k) Number
- K163609 FDA UDI
- FDA Product Code
- NHV FDA UDI
- GMDN Term
- Microbial water purification filter, non-sterilizable 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Pore Size — 0.2 Micrometer FDA UDI
Category: Microbial water purification filter, non-sterilizable
Pall QPoint® Filter Capsule by Pall International SARL — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microbial water purification filter, non-sterilizable.
- Disposable Water Filter FILTRAY 2G — Aqua-Tools · Class II
- Posiclear — MAR COR PURIFICATION, INC. · Class II
- Disposable Water Filter FILTRAY 2G — Aqua-Tools · Class II
- Nephros SSU-H UltraFilter — NEPHROS, INC. · Class II
- Disposable water filter Filt'Ray — Aqua-Tools · Class II
- Nephros DSU-H UltraFilter — NEPHROS, INC. · Class II
- Disposable water filter Filt'Ray — Aqua-Tools · Class II
- FILTER, RENAPURE 20" 222 FIN — Evoqua Water Technologies LLC · Class II
Cleared under the same submission
K163609 also covers:
- Pall QPoint® Disposable Water Filter — Global Life Sciences Solutions USA LLC
- Pall QPoint® Disposable Water Filter — Global Life Sciences Solutions USA LLC
- Pall QPoint® Disposable Water Filter — Global Life Sciences Solutions USA LLC
- Pall QPoint® Disposable Water Filter — Global Life Sciences Solutions USA LLC
- Pall QPoint Docking Station Shower — Pall International SARL
- Pall QPoint® Docking Station Shower — Pall International SARL
- Pall QPoint® Filter Capsule — Pall International SARL
- Pall QPoint® Filter Capsule — Pall International SARL
- Pall QPoint® Filter Capsule — Pall International SARL
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pall International SARL
Sources (1)
- FDA UDI c4401192-769d-42d1-9ac5-96b753152048 37 fields · synced Jun 8, 2026