FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Reliance Vision
DI: 00724995192679
·
Model: Single Chamber
·
Corporation Steris Canada
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Reliance Vision
- Primary DI
- 00724995192679
- Version / Model
- Single Chamber
- Catalog Number
- FH05063
- Company Name
- Corporation Steris Canada
- Labeler DUNS
- 202659140
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-04
- Public Version
- 4
- Public Version Date
- 2023-11-07
- Public Version Status
- Update
- Public Device Record Key
- e86c2cf2-913b-4bf8-88ae-569ff69354e9
- Distribution End Date
- 2023-11-06
Device Description
The Reliance Vision Single-Chamber Washer Disinfector, Electric 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), theater shoes and other similar and related items 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 |
|---|---|---|---|---|
| 66649 | Endoscope washer-disinfector (chemical) | An electrically-powered unit intended to be used for both washing and chemical disinfection of endoscopes, and their accessories. It has built-in features to circulate cleaning and disinfectant solutions through the lumen (flushing) of the endoscope; some types may also have built-in drying features. It is not intended for device sterilization. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00724995192679 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]