FDA UDI
In Commercial Distribution
🇺🇸 United States
AMSCO
DI: 00724995211028
·
Model: AMSCO 400 Steam Sterilizer
·
Steris Mexico, S. de R.L. de C.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AMSCO
- Primary DI
- 00724995211028
- Version / Model
- AMSCO 400 Steam Sterilizer
- Catalog Number
- SR3201111011
- Company Name
- Steris Mexico, S. de R.L. de C.V.
- Labeler DUNS
- 813116209
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-16
- Public Version
- 2
- Public Version Date
- 2021-11-16
- Public Version Status
- Update
- Public Device Record Key
- 6351e342-2de6-42ac-ac0e-d150ccfc42b3
Device Description
The AMSCO 400 Series 20 Steam Flush Pressure Pulse Steam Sterilizer Single Door Cabinet with pump is designed for sterilization of materials used 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
- No
- 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 |
|---|---|---|---|---|
| FLE | Sterilizer, steam | General Hospital | 880.6880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38671 | Steam sterilizer | A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00724995211028 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]