FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Reliance Vision
DI: 00724995152147
·
Model: Single Chamber
·
Corporation Steris Canada
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Reliance Vision
- Primary DI
- 00724995152147
- Version / Model
- Single Chamber
- Catalog Number
- FH05
- Company Name
- Corporation Steris Canada
- Labeler DUNS
- 202659140
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-13
- Public Version
- 6
- Public Version Date
- 2023-11-07
- Public Version Status
- Update
- Public Device Record Key
- da64cc97-8b49-441b-b704-47bcfbb7dd36
- Distribution End Date
- 2023-11-06
Device Description
The Reliance Vision Single-Chamber Washer Disinfector 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 | 00724995152147 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]