Identity
- Trade Name
- Amsco Evolution FDA UDI
- Generic Name
- Steam sterilizer FDA UDI
- Device Name
- The Amsco Evolution Floorloader - Large. This Amsco Evolution Prevacuum Steam Sterilizer is configured for Prevacuum sterilization of heat and moisture-stable materials used in healthcare facilities. These units are equipped with Prevacuum, Steam Flush Pressure Pulse (SFPP), gravity, liquid, Dart (Bowie-Dick) and vacuum leak test cycles. FDA UDI
- Model / Reference
- HC-2000 FDA UDI
- Description
- The Amsco Evolution Floorloader - Large. This Amsco Evolution Prevacuum Steam Sterilizer is configured for Prevacuum sterilization of heat and moisture-stable materials used in healthcare facilities. These units are equipped with Prevacuum, Steam Flush Pressure Pulse (SFPP), gravity, liquid, Dart (Bowie-Dick) and vacuum leak test cycles. FDA UDI
Identifiers
- Catalog Number
- UE43 FDA UDI
- Primary DI / UDI-DI
- 00724995151546 FDA UDI
- FDA Product Code
- FLE FDA UDI
- GMDN Term
- Steam sterilizer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Steam sterilizer
Amsco Evolution by Steris Mexico, S. de R.L. de C.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Steris Mexico, S. de R.L. de C.V.
Sources (1)
- FDA UDI a89a8f14-30d0-4c02-9584-f45024b95989 35 fields · synced May 30, 2026