FDA.reportPublic FDA data

AquaBrush System

Primary DI
00816185001165
Brand
AquaBrush System
Company
Torvan Medical Inc
Model
T12-TAB-402766
Catalog number
T12-TAB-402766
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.
Published
2025-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MNLAccessories, Cleaning Brushes, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816185001165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816185001165008161850011658161850011650816185001165

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument pre-cleaning washerAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
200280404
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816185001127Dovideq LeakControl DeviceT11-ASY-LEAKCONTROLT11-ASY-LEAKCONTROL2025-09-18
00816185000397EndoCab4362SCSHG-20PSD2-TSBC4362SCSHG-20PSD2-TSBC2024-05-10
00816185000403EndoCab4352SCSHG-16PSD2-TSBC4352SCSHG-16PSD2-TSBC2024-05-10
00816185000410EndoCab4342SCSHG-10PSD1-TSBC4342SCSHG-10PSD1-TSBC2024-05-10
00816185000427EndoCab4322SCSLG-6PSD1-TSBC4322SCSLG-6PSD1-TSBC2024-05-10
00816185000441EndoCab4362SCSHG-20PSD2-TSRF4362SCSHG-20PSD2-TSRF2024-05-10
00816185000458EndoCab4352SCSHG-16PSD2-TSRF4352SCSHG-16PSD2-TSRF2024-05-10
00816185000465EndoCab4342SCSHG-10PSD1-TSRF4342SCSHG-10PSD1-TSRF2024-05-10
00816185000472EndoCab4322SCSLG-6PSD1-TSRF4322SCSLG-6PSD1-TSRF2024-05-10
00816185000847EndoCab4261SCSHG-20PTD2-TSRF4261SCSHG-20PTD2-TSRF2024-05-10
00816185000854EndoCab4251SCSHG-16PTD2-TSRF4251SCSHG-16PTD2-TSRF2024-05-10
00816185000861EndoCab4241SCSHG-10PTD1-TSRF4241SCSHG-10PTD1-TSRF2024-05-10
00816185000915EndoCab4253SCSHG-5PTD1-TSRF4253SCSHG-5PTD1-TSRF2024-05-10
00816185000922EndoCab4253SCSHG-10PTD1-TSRF4253SCSHG-10PTD1-TSRF2024-05-10
00816185000991EndoCab4261SCSHG-20PTD2-TSBC4261SCSHG-20PTD2-TSBC2024-05-10
00816185001004EndoCab4251SCSHG-16PTD2-TSBC4251SCSHG-16PTD2-TSBC2024-05-10
00816185001011EndoCab4241SCSHG-10PTD1-TSBC4241SCSHG-10PTD1-TSBC2024-05-10
00816185001066EndoCab4253SCSHG-5PTD1-TSBC4253SCSHG-5PTD1-TSBC2024-05-10
00816185001073EndoCab4253SCSHG-10PTD1-TSBC4253SCSHG-10PTD1-TSBC2024-05-10
00816185001141AutoSink with Endoscope Leak TesterT9-1B-3430HA-AST9-1B-3430HA-AS2025-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489008562MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10193489008579MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10193489091915MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10620974004308Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-05-30
10620974004315Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-05-30
10620974004216Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004223Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004230Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004247Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004254Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004261Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
H816SMQEZ21Spec Clean Endoscope SpongeMicroCare, LLCMNL2023-08-30
H816QEZ21QEZCERTOL INTERNATIONAL, LLCMNL2023-06-02
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