Duns Number:070164694
Device Description: Dri-Scope Aid-Cabinet [Gen 2]; Regulator Wall; Series 1840; DSC2-RW3-TSI; TRICOR Label;Dri Dri-Scope Aid-Cabinet [Gen 2]; Regulator Wall; Series 1840; DSC2-RW3-TSI; TRICOR Label;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 indefinitely until the endoscope is removed from the system. This (TRICOR Systems Inc - built / TRICOR Systems Inc - labeled) wall-mounted regulator version is one component of the Dri-Scope Aid – Cabinet system that contains a precision regulator used to provide HEPA filtered air to other parts of the system from an external medical air source. This regulator component is used along with 2 (or 1) of the Dri-Scope Aid - Manifolds which together works as a drying system.
Catalog Number
DCRW-TSI2
Brand Name
Dri-Scope Aid - [Gen 2] Cabinet - Regulator Wall (R3) - Series 1840
Version/Model Number
DCRW-TSI2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MNL
Product Code Name
Accessories, Cleaning Brushes, For Endoscope
Public Device Record Key
5261d33e-315d-4750-a66b-8c2b2e9855a0
Public Version Date
February 16, 2022
Public Version Number
1
DI Record Publish Date
February 08, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 48 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |