Amsco Evolution UE42

GUDID 00724995151577

The Amsco Evolution Floorloader - Large. This Amsco Evolution SFPP 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.

Steris Mexico, S. de R.L. de C.V.

Steam sterilizer

• Primary Device ID: 00724995151577
• NIH Device Record Key: 097eb1b9-92a9-4e8c-aee1-d395bce4a220
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amsco Evolution
• Version Model Number: HC-3000
• Catalog Number: UE42
• Company DUNS: 813116209
• Company Name: Steris Mexico, S. de R.L. de C.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995151577 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092490

FDA Product Code

• FLE: Sterilizer, steam

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-20
• Device Publish Date: 2016-09-14

On-Brand Devices [Amsco Evolution]

• 00724995151638: The Amsco Evolution - Medium Steam Sterilizer. Amsco Evolution SFPP Steam Sterilizers are config
• 00724995151621: The Amsco Evolution - Medium Steam Sterilizer. Amsco Evolution Prevac Steam Sterilizers are conf
• 00724995151614: TThe Amsco Evolution - Medium Steam Sterilizer. Amsco Evolution SFPP Steam Sterilizers are confi
• 00724995151607: The Amsco Evolution - Medium Steam Sterilizer. Amsco Evolution Prevac Steam Sterilizers are conf
• 00724995151591: The Amsco Evolution - Medium Steam Sterilizer. Amsco Evolution SFPP Steam Sterilizers are config
• 00724995151584: The Amsco Evolution - Medium Steam Sterilizer. Amsco Evolution Prevac Steam Sterilizers are conf
• 00724995151577: The Amsco Evolution Floorloader - Large. This Amsco Evolution SFPP Steam Sterilizer is configure
• 00724995151560: The Amsco Evolution Floorloader - Large. This Amsco Evolution Prevac Steam Sterilizer is config
• 00724995151553: The Amsco Evolution Floorloader - Large. This Amsco Evolution SFPP Steam Sterilizer is configur
• 00724995151546: The Amsco Evolution Floorloader - Large. This Amsco Evolution Prevac Steam Sterilizer is configu
• 00724995151539: The Amsco Evolution - Medium Steam Sterilizer. Amsco Evolution SFPP Steam Sterilizers are config
• 00724995151522: The Amsco Evolution - Medium Steam Sterilizer. Amsco Evolution Prevac Steam Sterilizers are conf
• 00724995151515: The Amsco Evolution - Medium Steam Sterilizer. Amsco Evolution SFPP Steam Sterilizers are config
• 00724995151508: The Amsco Evolution - Medium Steam Sterilizer. Amsco Evolution Prevac Steam Sterilizers are conf
• 00724995151492: The Amsco Evolution - Medium Steam Sterilizer. Amsco Evolution SFPP Steam Sterilizers are config
• 00724995151485: The Amsco Evolution - Medium Steam Sterilizer. Amsco Evolution Prevac Steam Sterilizers are conf