Tyvek® 12544

GUDID 20705037015921

Tyvek® Heat Seal Pouch with STERRAD™ Chemical Indicator 200 mm x 650 mm (8" x 25.5")

ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Chemical/physical sterilization process indicator

• Primary Device ID: 20705037015921
• NIH Device Record Key: edcc3948-94c6-4dcb-9993-1130da4e53c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tyvek®
• Version Model Number: 12544
• Catalog Number: 12544
• Company DUNS: 947451626
• Company Name: ADVANCED STERILIZATION PRODUCTS SERVICES INC.
• Device Count: 100
• 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: true
• 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
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD™ Sterilizer both before and after sterilization.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD™ Sterilizer both before and after sterilization.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD™ Sterilizer both before and after sterilization.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD™ Sterilizer both before and after sterilization.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD™ Sterilizer both before and after sterilization.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD™ Sterilizer both before and after sterilization.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD™ Sterilizer both before and after sterilization.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD™ Sterilizer both before and after sterilization.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD™ Sterilizer both before and after sterilization.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD™ Sterilizer both before and after sterilization.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705037015924 [Primary]
GS1	20705037015921 [Package]; Contains: 10705037015924; Package: Case [4 Units]; In Commercial Distribution
GS1	80705037015923 [Unit of Use]

FDA Product Code

• JOJ: Indicator, physical/chemical sterilization process

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: 2025-12-25
• Device Publish Date: 2025-12-17

On-Brand Devices [Tyvek®]

• 20705037015914: Tyvek® Heat Seal Pouch with STERRAD™ Chemical Indicator 200 mm x 500 mm (8" x 20")
• 20705037015969: Tyvek® Heat Seal Pouch with STERRAD™ Chemical Indicator 300 mm x 650 mm (12" x 25.5")
• 20705037015952: Tyvek® Heat Seal Pouch with STERRAD™ Chemical Indicator 250 mm x 750 mm (10" x 29.5")
• 20705037015945: Tyvek® Heat Seal Pouch with STERRAD™ Chemical Indicator 250 mm x 600 mm (10" x 23.5")
• 20705037015921: Tyvek® Heat Seal Pouch with STERRAD™ Chemical Indicator 200 mm x 650 mm (8" x 25.5")
• 20705037015976: Tyvek® Heat Seal Pouch with STERRAD™ Chemical Indicator 350 mm x 750 mm (13.75" x 29.5")