Identity
- Trade Name
- Pall-Aquasafe™ Detachable Shower Rose FDA UDI
- Generic Name
- Wound irrigation nozzle FDA UDI
- Device Name
- Detachable Shower Rose - For use with Pall-Aquasafe Water Filter - Faucet (AQ31F1SA) for 31 day use FDA UDI
- Model / Reference
- AQROSEA FDA UDI
- Description
- Detachable Shower Rose - For use with Pall-Aquasafe Water Filter - Faucet (AQ31F1SA) for 31 day use FDA UDI
Identifiers
- Catalog Number
- AQROSEA FDA UDI
- Primary DI / UDI-DI
- 05034480314802 FDA UDI
- 510(k) Number
- K153434 FDA UDI
- FDA Product Code
- NHV FDA UDI
- GMDN Term
- Wound irrigation nozzle 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: Wound irrigation nozzle
Pall-Aquasafe™ Detachable Shower Rose by Pall International SARL — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 38990289-a420-47ea-98cd-0a03190ca1ac 37 fields · synced May 30, 2026