STERRAD SEALSURE 14202NL

GUDID 20705037067258

Chemical Indicator Tape

ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator

• Primary Device ID: 20705037067258
• NIH Device Record Key: bc514743-5f20-4e1c-bd96-83b74f9a3108
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERRAD SEALSURE
• Version Model Number: 14202NL
• Catalog Number: 14202NL
• 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: 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: 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

• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator.
• Special Storage Condition, Specify: Between 0 and 0 *Before and after processing, store away from sterilizer or sources of ethylene oxide, hydrogen peroxide and strong acids.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705037067244 [Primary]
GS1	20705037067258 [Package]; Contains: 10705037067244; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040742

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: 2021-02-19
• Device Publish Date: 2021-02-11

On-Brand Devices [STERRAD SEALSURE]

• 20705037016201: Chemical Indicator Tape
• 20705037067258: Chemical Indicator Tape