AccessGUDID - DEVICE: Dri-Scope Aid - [Gen 2] Cabinet - Manifold (M1R)

GUDID

Device Identifier (DI) Information

Brand Name: Dri-Scope Aid - [Gen 2] Cabinet - Manifold (M1R) - Series 3308
Version or Model: DC2M3308-TSI
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DC2M3308-TSI
Company Name: TRICOR SYSTEMS, INC.

Primary DI Number: 00810053600559
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070164694 *Terms of Use

Device Description: Dri-Scope Aid-Cabinet [Gen 2]; Manifold; Series 3308; DSC2-M1-3308-TSI-R; TRICOR Label; Refurbished; Dri-Scope Aid - Cabinet Gen 2 system is intended to aid in drying and venting internal channels of cleaned and disinfected endoscopes. The system is designed to cost-effectively convert existing passive cabinets (or closets) to active drying cabinets (or closets). The system can process as many as 16 endoscopes that are waiting in the queue. It provides pressure sensitive continuous flow of clean HEPA filtered air. Simply attach the endoscope, press the button to place the endoscope in the processing queue and the system will take care of the rest. After the drying cycle is complete, the system will periodically cycle dry air through the endoscope internal channels on a timed basis around the clock. This (TRICOR Systems Inc - built / TRICOR Systems Inc - labeled) 33” wide / 8 port manifold is one component of the Dri-Scope Aid – Cabinet system that receives the HEPA filtered air from the system pump and distributes it to the endoscope(s) for the purpose of drying and venting.

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":	Yes
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?
65046	Endoscope dryer	An electrically-powered assembly of devices designed to dry the internal channel of an endoscope after washing, and to maintain dryness during storage, to prevent bacterial growth and endoscope deterioration. It consists of a user interface, a control unit, tubing/connectors for attaching to the endoscope, and may incorporate either an internal air pump or a connection for standard medical air supply; it may be designed for use on a bench or in a cabinet.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNL	Accessories, Cleaning Brushes, 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: d4087aad-99c5-4dcf-95d8-c5e0ad41b9b1
Public Version Date: March 10, 2023
Public Version Number: 1
DI Record Publish Date: March 02, 2023