Rapicide PA Test Strips

GUDID 30677964064075

MEDIVATORS INC.

Peracetic acid device disinfectant/sterilant test strip

• Primary Device ID: 30677964064075
• NIH Device Record Key: 5b2b8c65-c54c-43c5-b932-91298ed7f0c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rapicide PA Test Strips
• Version Model Number: ML02-0118
• Company DUNS: 068199363
• Company Name: MEDIVATORS INC.
• Device Count: 100
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00677964064074 [Unit of Use]
GS1	10677964064071 [Primary]
GS1	30677964064075 [Package]; Contains: 10677964064071; Package: Box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152394

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: 3
• Public Version Date: 2020-11-02
• Device Publish Date: 2018-02-26

Devices Manufactured by MEDIVATORS INC.

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