FDA UDI
In Commercial Distribution
🇺🇸 United States
Pall-Aquasafe™ Detachable Shower Rose
DI: 05034480314802
·
Model: AQROSEA
·
Pall International Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Pall-Aquasafe™ Detachable Shower Rose
- Primary DI
- 05034480314802
- Version / Model
- AQROSEA
- Catalog Number
- AQROSEA
- Company Name
- Pall International Sàrl
- Labeler DUNS
- 485050483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-20
- Public Version
- 5
- Public Version Date
- 2026-02-23
- Public Version Status
- Update
- Public Device Record Key
- 38990289-a420-47ea-98cd-0a03190ca1ac
Device Description
Detachable Shower Rose - For use with Pall-Aquasafe Water Filter - Faucet (AQ31F1SA) for 31 day use
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NHV | SYSTEM, WATER PURIFICATION, GENERAL MEDICAL USE | Gastroenterology, Urology | 876.5665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61121 | Wound irrigation nozzle | A device intended to be fitted to a microbial water purification filter to direct a flow of purified water for wound washing/irrigation, especially of an immunocompromised patient, and is also typically intended to assist in protecting the filter from retrograde contamination; it is not primarily intended for intraoperative use. It is typically designed as a moulded nozzle (e.g., shower rose). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 35034480314803 | GS1 | case | 25 | In Commercial Distribution | |
| Primary | 05034480314802 | GS1 |
Customer Contacts
- Phone
- +1(800)645-6578 ext. 5164843600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153434 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Pore Size | 0.2 | Micrometer |