Tyvek Roll 12450

GUDID 20705037015860

Tyvek Roll with Sterrad Chemical Indicator 500 mm x 70 m

ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use

• Primary Device ID: 20705037015860
• NIH Device Record Key: fa9eeee4-a61d-4430-bc66-eda0ccfadfbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tyvek Roll
• Version Model Number: 12450
• Catalog Number: 12450
• 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: 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: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@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.
• 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.
• 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.
• 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.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705037015863 [Primary]
GS1	20705037015860 [Package]; Contains: 10705037015863; Package: Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103210

FDA Product Code

• FRG: Wrap, sterilization

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: 2019-11-08
• Device Publish Date: 2016-09-24

On-Brand Devices [Tyvek Roll]

• 20705037015860: Tyvek Roll with Sterrad Chemical Indicator 500 mm x 70 m
• 20705037015853: Tyvek Roll with Sterrad Chemical Indicator 420 mm x 70 m
• 20705037015846: Tyvek Roll with Sterrad Chemical Indicator 350 mm x 70 m
• 20705037015839: Tyvek Roll with Sterrad Chemical Indicator 250 mm x 70 m
• 20705037015822: Tyvek Roll with Sterrad Chemical Indicator 200 mm x 70 m
• 20705037015815: Tyvek Roll with Sterrad Chemical Indicator 150 mm x 70 m
• 20705037015808: Tyvek Roll with Sterrad Chemical Indicator 100 mm x 70 m
• 20705037015792: Tyvek Roll with Sterrad Chemical Indicator 75 mm x 70 m