FDA UDI
In Commercial Distribution
🇺🇸 United States
AMSCO
DI: 00724995192976
·
Model: 5052
·
Corporation Steris Canada
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AMSCO
- Primary DI
- 00724995192976
- Version / Model
- 5052
- Catalog Number
- FH14072
- 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
- 3
- Public Version Date
- 2023-02-27
- Public Version Status
- Update
- Public Device Record Key
- ae2f9676-5149-4714-a30c-2ead43bbac67
Device Description
The AMSCO 5052 Single-Chamber Washer-Disinfector, double-door, steam unit is designed for use in the cleaning and intermediate-level disinfection of soiled reusable utensils, trays, bedpans and urinals. It can also be used for rubber and plastic goods, simple hard-surfaced rigid surgical instruments (such as forceps and clamps) and other similar and 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 |
|---|---|---|---|---|
| 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 | 00724995192976 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]