Revital-Ox 4453AW

GUDID 50724995216929

Revital-Ox PAA HLD Solution Part A is used Revital-Ox PAA HLD Part B and the enspire 300 Series Automated Endoscope Reprocessor

STERIS CORPORATION

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• Primary Device ID: 50724995216929
• NIH Device Record Key: 8527814b-c5b2-4dbb-bda0-7fa8ecec5ca2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revital-Ox
• Version Model Number: 4453AW
• Catalog Number: 4453AW
• 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: false
• 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: false

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995216924 [Primary]
GS1	50724995216929 [Package]; Contains: 00724995216924; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230560

FDA Product Code

• MED: Sterilant, medical devices

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: 2024-04-25
• Device Publish Date: 2024-04-17

On-Brand Devices [Revital-Ox]

• 00724995094850: Revital-Ox Flexible Container Round is for the transport or soaking of rigid endoscopes.
• 00724995094843: Revital-Ox Rigid Container System is for the transport or soaking of rigid endoscopes and access
• 50724995216929: Revital-Ox PAA HLD Solution Part A is used Revital-Ox PAA HLD Part B and the enspire 300 Series
• 50724995216905: Revital-Ox PAA HLD Solution Part B is used Revital-Ox PAA HLD Part A and the enspire 300 Series