FDA UDI
In Commercial Distribution
🇺🇸 United States
Reliance Vision
DI: 00724995193249
·
Model: Multi-Chamber
·
Corporation Steris Canada
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Reliance Vision
- Primary DI
- 00724995193249
- Version / Model
- Multi-Chamber
- Catalog Number
- FH92042
- Company Name
- Corporation Steris Canada
- Labeler DUNS
- 202659140
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-04
- Public Version
- 4
- Public Version Date
- 2023-11-21
- Public Version Status
- Update
- Public Device Record Key
- 53ae033e-ea2a-4232-85b4-beeb9f1e5dc5
Device Description
The Reliance Vision Multi-Chamber Washer Disinfector Sonic Unit is intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments (such as forceps and clamps) and other related articles found in healthcare facilities.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| MEC | Disinfector, medical devices | General Hospital | 880.6992 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66797 | Surgical instrument washer/disinfector (chemical/thermal) | An electrically-powered unit intended to both wash and disinfect a range of surgical instruments, and typically also ancillary utensils (e.g., containers), using both heat and a disinfectant solution; it is not dedicated to washing/disinfecting a specific device type. The device includes an internal chamber containing baskets/racks onto which the devices are placed to help maximize contact with all surfaces and parts. It is used in hospitals typically in a reprocessing suite. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00724995193249 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]