S40 S4000

GUDID 10724995090729

The S40 Sterilant Concentrate is a single use peracetic acid-based chemistry used in the SYSTEM 1E and SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems. The net contents are 194.2g per cup.

STERIS CORPORATION

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• Primary Device ID: 10724995090729
• NIH Device Record Key: 64409ede-55eb-4a3a-b456-9c929fd3b8cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S40
• Version Model Number: S4000
• Catalog Number: S4000
• Company DUNS: 828222781
• Company Name: STERIS CORPORATION
• 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(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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Device Dimensions

• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram
• Weight: 194 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep upright, dry, away from sunlight, and away from heat or open flame.
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995090722 [Primary]
GS1	10724995090729 [Package]; Contains: 00724995090722; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090036

FDA Product Code

• MED: Sterilant, medical devices

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: 2018-11-28
• Device Publish Date: 2016-09-08

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• 50724995216905 - Revital-Ox: 2024-04-25 Revital-Ox PAA HLD Solution Part B is used Revital-Ox PAA HLD Part A and the enspire 300 Series Automated Endoscope Reprocessor
• 50724995216929 - Revital-Ox: 2024-04-25 Revital-Ox PAA HLD Solution Part A is used Revital-Ox PAA HLD Part B and the enspire 300 Series Automated Endoscope Reprocessor
• 00724995217587 - NA: 2024-04-25 enspire 300 Connector Olympus Channel Separator is used with the enspire 300 Series Automated Endoscope Reprocessor
• 00724995217594 - NA: 2024-04-25 enspire 300 Connector Olympus Channel Separator is used with the enspire 300 Series Automated Endoscope Reprocessor
• 00724995217600 - NA: 2024-04-25 enspire 300 Connector Olympus Air Water Valve is used with the enspire 300 Series Automated Endoscope Reprocessor
• 00724995217617 - NA: 2024-04-25 enspire 300 Connector Olympus Air Water Valve is used with the enspire 300 Series Automated Endoscope Reprocessor
• 00724995217624 - NA: 2024-04-25 enspire 300 Connector Olympus Suction Valve is used with the enspire 300 Series Automated Endoscope Reprocessor
• 00724995217631 - NA: 2024-04-25 enspire 300 Connector Olympus Suction Valve is used with the enspire 300 Series Automated Endoscope Reprocessor