Duns Number:070164694
Device Description: Dri-Scope Aid-Jet Stream; Pump BL1; Model 1840P; DSA3-P2-TSI; TRICOR Label;The Dri-Scope A Dri-Scope Aid-Jet Stream; Pump BL1; Model 1840P; DSA3-P2-TSI; TRICOR Label;The Dri-Scope Aid Jet-Stream (Model 1840P) is a counter-top (or pole/wall mounted) device designed to assist in the drying of internal channels of an endoscope at the point of cleaning. The device's internal pump provides a constant flow of 0.1um HEPA-filtered air to aid in the drying process after high-level cleaning and disinfecting has been done. Dual-port, dual-timer allows one (or two) endoscopes to be connected simultaneously for drying. The programmable device provides automatic high pressure shutoff protection as well as air filter performance monitoring to assure proper pressure and air flow.
Catalog Number
402119-101BL1-TSI
Brand Name
Dri-Scope Aid - Jet Stream - Pump (P2)
Version/Model Number
402119-101BL1-TSI
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
4e36c5c3-ca9f-40c5-a9c2-520e938cb878
Public Version Date
August 28, 2020
Public Version Number
1
DI Record Publish Date
August 20, 2020
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 |