Identity
- Trade Name
- Disposable water filter Filt'Ray FDA UDI
- Generic Name
- Microbial water purification filter, non-sterilizable FDA UDI
- Device Name
- 3 months - FILT'RAY 2G Compact shower hand water filter FDA UDI
- Model / Reference
- AT20361US FDA UDI
- Description
- 3 months - FILT'RAY 2G Compact shower hand water filter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760279733500 FDA UDI
- 510(k) Number
- K191563 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Microbial water purification filter, non-sterilizable
Disposable water filter Filt'Ray by Aqua-Tools — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Microbial water purification filter, non-sterilizable.
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Cleared under the same submission
K191563 also covers:
- Disposable Water Filter FILTRAY 2G — Aqua-Tools
- Disposable Water Filter FILTRAY 2G — Aqua-Tools
- Disposable Water Filter FILTRAY 2G — Aqua-Tools
- Disposable Water Filter FILTRAY 2G — Aqua-Tools
- Disposable Water Filter FILTRAY 2G — Aqua-Tools
- Disposable Water Filter FILTRAY 2G — Aqua-Tools
- Disposable Water Filter FILTRAY 2G — Aqua-Tools
- Disposable Water Filter FILTRAY 2G — Aqua-Tools
- Disposable Water Filter FILTRAY 2G — Aqua-Tools
- Disposable Water Filter FILTRAY 2G — Aqua-Tools
- Disposable Water Filter FILTRAY 2G — Aqua-Tools
- Disposable Water Filter FILTRAY 2G — Aqua-Tools
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
- Aqua-Tools
Sources (1)
- FDA UDI a5a6db92-98c2-4c5f-b6bf-1d68437a6b1d 35 fields · synced May 30, 2026