Amsco Evolution UE01

GUDID 00724995151638

The Amsco Evolution - Medium Steam Sterilizer. Amsco Evolution SFPP Steam Sterilizers are configured for prevacuum sterilization of heat and moisture-stable materials used in healthcare facilities. These units can be equipped with prevacuum, Steam Flush Pressure Pulse (SFPP), gravity, liquid, and daily air removal test cycles.

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

Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer

• Primary Device ID: 00724995151638
• NIH Device Record Key: c261f57e-dcc0-4b01-b688-6acf0329a46b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amsco Evolution
• Version Model Number: HC-900
• Catalog Number: UE01
• 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	00724995151638 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091136

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