AEROZYME™ XTRA 25520

GUDID 20705037048752

AEROZYME™ XTRA Multi Enzymatic Detergent

ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Medical device cleaning agent

• Primary Device ID: 20705037048752
• NIH Device Record Key: 1a2ad62e-30b2-46d9-bcb8-fe7c3aac8369
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AEROZYME™ XTRA
• Version Model Number: 25520
• Catalog Number: 25520
• Company DUNS: 947451626
• Company Name: ADVANCED STERILIZATION PRODUCTS SERVICES INC.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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(888)783-7723
• Email: asp-contactus@asp.com
• Phone: +1(888)783-7723
• Email: asp-contactus@asp.com
• Phone: +1(888)783-7723
• Email: asp-contactus@asp.com
• Phone: +1(888)783-7723
• Email: asp-contactus@asp.com
• Phone: +1(888)783-7723
• Email: asp-contactus@asp.com
• Phone: +1(888)783-7723
• Email: asp-contactus@asp.com
• Phone: +1(888)783-7723
• Email: asp-contactus@asp.com
• Phone: +1(888)783-7723
• Email: asp-contactus@asp.com
• Phone: +1(888)783-7723
• Email: asp-contactus@asp.com
• Phone: +1(888)783-7723
• Email: asp-contactus@asp.com
• Phone: +1(888)783-7723
• Email: asp-contactus@asp.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705037048755 [Primary]
GS1	20705037048752 [Package]; Contains: 10705037048755; Package: Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181472

FDA Product Code

• MED: Sterilant, medical devices

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-24
• Device Publish Date: 2025-12-16

Devices Manufactured by ADVANCED STERILIZATION PRODUCTS SERVICES INC.

• 20705037015976 - Tyvek®: 2025-12-26 Tyvek® Heat Seal Pouch with STERRAD™ Chemical Indicator 350 mm x 750 mm (13.75" x 29.5")
• 20705037015921 - Tyvek®: 2025-12-25 Tyvek® Heat Seal Pouch with STERRAD™ Chemical Indicator 200 mm x 650 mm (8" x 25.5")
• 20705037015945 - Tyvek®: 2025-12-25 Tyvek® Heat Seal Pouch with STERRAD™ Chemical Indicator 250 mm x 600 mm (10" x 23.5")
• 20705037015952 - Tyvek®: 2025-12-25 Tyvek® Heat Seal Pouch with STERRAD™ Chemical Indicator 250 mm x 750 mm (10" x 29.5")
• 20705037015969 - Tyvek®: 2025-12-25 Tyvek® Heat Seal Pouch with STERRAD™ Chemical Indicator 300 mm x 650 mm (12" x 25.5")
• 20705037015914 - Tyvek®: 2025-12-24 Tyvek® Heat Seal Pouch with STERRAD™ Chemical Indicator 200 mm x 500 mm (8" x 20")
• 20705037018069 - ENZOL™: 2025-12-24 ENZOL™ Enzymatic Detergent - 1 Gallon
• 10705037018123 - ENZOL™: 2025-12-24 ENZOL™ Enzymatic Detergent- 15 Gallon