VAPROX PB011

GUDID 50724995153095

VAPROX HC Sterilant is 59 percent Hydrogen Peroxide, designed specifically for use in the V-PRO Low Temperature Sterilization Systems. The cup carries RFID tag. Net contents 3 - 113 mL per cup.

STERIS CORPORATION

Hydrogen peroxide device sterilant

• Primary Device ID: 50724995153095
• NIH Device Record Key: b8010cdf-1327-4a5e-83c2-451b30d24a2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VAPROX
• Version Model Number: PB011
• Catalog Number: PB011
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995153090 [Primary]
GS1	50724995153095 [Package]; Contains: 00724995153090; Package: Case [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172754

FDA Product Code

• MLR: Sterilizer, chemical

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: 2018-09-24
• Device Publish Date: 2018-08-23

On-Brand Devices [VAPROX]

• 50724995153101: VAPROX HC Sterilant is 59 percent Hydrogen Peroxide used with V-PRO Low Temperature Sterilizatio
• 50724995153095: VAPROX HC Sterilant is 59 percent Hydrogen Peroxide, designed specifically for use in the V-PRO
• 10724995089518: The VAPROX HC Sterilant uses 59 percent Hydrogen Peroxide that is used with V-PRO Low Temperatur
• 10724995089167: The VAPROX HC Sterilant uses 59 percent Hydrogen Peroxide and is used with V-PRO Low Temperature