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

• 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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• 10724995091146: The VERIFY SixCess 270FP Challenge Packs are designed for process challenge testing of steam ste
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• 10724995088955: The VERIFY SixCess 270F 4 Challenge Packs are used to monitor steam sterilization loads and can
• 10724995218574: The VERIFY SixCess 275F 3 Challenge Packs are used to monitor steam sterilization loads and can
• 10724995218567: The VERIFY SixCess 270FP Challenge Packs are designed for process challenge testing of steam ste
• 10724995218550: The VERIFY SixCess 270F 4 Challenge Packs are used to monitor steam sterilization loads and can