AccessGUDID - DEVICE: AutoSink with Endoscope Leak Tester (00816185001141)

GUDID

Device Identifier (DI) Information

Brand Name: AutoSink with Endoscope Leak Tester
Version or Model: T9-1B-3430HA-AS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T9-1B-3430HA-AS
Company Name: Torvan Medical Inc

Primary DI Number: 00816185001141
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 200280404 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCY	Bulb, Inflation, For Endoscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 94656696-fe1c-4572-a8cd-24dd8ceac093
Public Version Date: May 06, 2025
Public Version Number: 1
DI Record Publish Date: April 28, 2025