FDA UDI
In Commercial Distribution
🇺🇸 United States
AutoSink with Endoscope Leak Tester
DI: 00816185001141
·
Model: T9-1B-3430HA-AS
·
Torvan Medical Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AutoSink with Endoscope Leak Tester
- Primary DI
- 00816185001141
- Version / Model
- T9-1B-3430HA-AS
- Catalog Number
- T9-1B-3430HA-AS
- Company Name
- Torvan Medical Inc
- Labeler DUNS
- 200280404
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-28
- Public Version
- 1
- Public Version Date
- 2025-05-06
- Public Version Status
- New
- Public Device Record Key
- 94656696-fe1c-4572-a8cd-24dd8ceac093
Device Description
The AutoSink supplements the manual cleaning process of endoscopes with added efficiencies and automations. Additionally providing early detection of small holes in the exterior of an endoscope through the observed detection of bubbles after submersion, it contributes to best practice, but does not replace required disinfection and maintainence.
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 |
|---|---|---|---|---|
| FCY | Bulb, Inflation, For Endoscope | Gastroenterology, Urology | 876.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37006 | Invasive medical device leak tester, electrical | An electrically-powered device intended to test an invasive medical device (e.g., flexible endoscope, ultrasound transducer) for leaks of air and/or fluid from its internal channels and/or housing by introducing air at increased pressures. It typically incorporates an electric pump with a manometer and controls intended to be connected to the device tested. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816185001141 | GS1 |