Tyvek Self Seal Pouch 12340

GUDID 20705037015754

Tyvek Self Seal Pouch with Sterrad Chemical Indicator 200 mm x 400 mm

ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Sterilization packaging, single-use

• Primary Device ID: 20705037015754
• NIH Device Record Key: fdce4f61-fc40-40dc-99f2-5e227eb80f8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tyvek Self Seal Pouch
• Version Model Number: 12340
• Catalog Number: 12340
• Company DUNS: 947451626
• Company Name: ADVANCED STERILIZATION PRODUCTS SERVICES INC.
• Device Count: 250
• 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: true
• 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	10705037015757 [Primary]
GS1	20705037015754 [Package]; Contains: 10705037015757; Package: Case [2 Units]; In Commercial Distribution
GS1	80705037015756 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103210

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: 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 Self Seal Pouch]

• 20705037015785: Tyvek Self Seal Pouch with Sterrad Chemical Indicator 320 mm x 560 mm
• 20705037015778: Tyvek Self Seal Pouch with Sterrad Chemical Indicator 250 mm x 480 mm
• 20705037015761: Tyvek Self Seal Pouch with Sterrad Chemical Indicator 150 mm x 420 mm
• 20705037015754: Tyvek Self Seal Pouch with Sterrad Chemical Indicator 200 mm x 400 mm
• 20705037015747: Tyvek Self Seal Pouch with Sterrad Chemical Indicator 100 mm x 350 mm
• 20705037015730: Tyvek Self Seal Pouch with Sterrad Chemical Indicator 150 mm x 320 mm
• 20705037015723: Tyvek Self Seal Pouch with Sterrad Chemical Indicator 100 mm x 260 mm
• 20705037015716: Tyvek Self Seal Pouch with Sterrad Chemical Indicator 75 mm x 200 mm