FDA UDI
In Commercial Distribution
🇺🇸 United States
AMSCO
DI: 00724995214463
·
Model: 1215
·
Corporation Steris Canada
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AMSCO
- Primary DI
- 00724995214463
- Version / Model
- 1215
- Catalog Number
- FW12103
- Company Name
- Corporation Steris Canada
- Labeler DUNS
- 202659140
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-13
- Public Version
- 3
- Public Version Date
- 2023-11-21
- Public Version Status
- Update
- Public Device Record Key
- 4a1dba3f-5e25-4a59-927c-62cdeb404abb
Device Description
AMSCO 1215 Cart and Utensil Washer/Disinfector, 380-400-415V, 50hz, Steam Heated has a small footprint that maximizes experiences by significantly reducing manual cleaning of case carts and containers.
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 | 00724995214463 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]