VERIFY SixCess LCC019

GUDID 10724995091146

The VERIFY SixCess 270FP Challenge Packs are designed for process challenge testing of steam sterilizers using standard and extended cycles.

STERIS CORPORATION

Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator

• Primary Device ID: 10724995091146
• NIH Device Record Key: 273257cc-1a13-4917-9801-26ca4f38a28a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERIFY SixCess
• Version Model Number: LCC019
• Catalog Number: LCC019
• Company DUNS: 961394798
• Company Name: STERIS CORPORATION
• Device Count: 20
• 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(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct light
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995091149 [Unit of Use]
GS1	10724995091146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103053

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: 5
• Public Version Date: 2020-11-03
• Device Publish Date: 2016-09-09

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• 10724995218550: The VERIFY SixCess 270F 4 Challenge Packs are used to monitor steam sterilization loads and can