FDA UDI
In Commercial Distribution
🇺🇸 United States
AquaBrush System
DI: 00816185001165
·
Model: T12-TAB-402766
·
Torvan Medical Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AquaBrush System
- Primary DI
- 00816185001165
- Version / Model
- T12-TAB-402766
- Catalog Number
- T12-TAB-402766
- Company Name
- Torvan Medical Inc
- Labeler DUNS
- 200280404
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-08
- Public Version
- 1
- Public Version Date
- 2025-12-16
- Public Version Status
- New
- Public Device Record Key
- dc7ebcb0-89cc-45d9-9c52-d8c6a784f9d6
Device Description
A fully enclosed pre-cleaning washer that augments the manual brushing stage of cleaning, to be used in conjunction with standard IFU procedures prior to disinfection/sterilization.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MNL | Accessories, Cleaning Brushes, For Endoscope | Gastroenterology, Urology | 876.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67328 | Surgical instrument pre-cleaning washer | An electrically-powered automated or semi-automated unit intended to use high pressure water for the initial pre-cleaning and washing of surgical instruments and devices prior to disinfection/sterilization; it is not dedicated to washing a specific type of devices. It is similar to a dishwasher with an internal chamber containing baskets/racks onto which the devices are placed to help maximize contact with all surfaces and parts. It is used in hospitals typically in a washing and reprocessing room. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816185001165 | GS1 |