FDA UDI
In Commercial Distribution
🇺🇸 United States
Dri-Scope Aid - Jet Stream - Regulator (R2)
DI: 00810053600382
·
Model: DSA3-R2-TSI
·
TRICOR SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Dri-Scope Aid - Jet Stream - Regulator (R2)
- Primary DI
- 00810053600382
- Version / Model
- DSA3-R2-TSI
- Catalog Number
- 402119-101RBL-TSI
- Company Name
- TRICOR SYSTEMS, INC.
- Labeler DUNS
- 070164694
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-31
- Public Version
- 1
- Public Version Date
- 2022-02-08
- Public Version Status
- New
- Public Device Record Key
- 88a8c364-d51b-4cb9-81a2-28245cef6e6e
Device Description
Dri-Scope Aid-Jet Stream; Regulator; Model 1840R; DSA3-R2-TSI; TRICOR Label; The Dri-Scope Aid Jet-Stream (Model 1840R) 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 pressure regulator provides and distributes a constant flow of 0.1um HEPA-filtered externally supplied medical air to aid in the drying process after high-level cleaning and disinfecting. Dual-port, dual-timer allows one (or two) endoscopes to be connected simultaneously for drying. The device provides precision regulated air as well as air filter performance monitoring to assure proper pressure and air flow.
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
- No
- 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 |
|---|---|---|---|---|
| MNL | Accessories, Cleaning Brushes, For Endoscope | Gastroenterology, Urology | 876.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810053600382 | GS1 |
Customer Contacts
- Phone
- 1-847-742-5542
- [email protected]