RAPICIDE PA PART A 3X5

GUDID 40677964023604

MEDIVATORS INC.

Medical device disinfection agent

• Primary Device ID: 40677964023604
• NIH Device Record Key: fc3ee563-4144-47d3-b7f4-82f1370f8b41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAPICIDE PA PART A 3X5
• Version Model Number: ML02-PTA13
• Company DUNS: 068199363
• Company Name: MEDIVATORS INC.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	40677964021389 [Package]; Package: [3 Units]; In Commercial Distribution
GS1	40677964023604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082988

FDA Product Code

• FEB: Accessories, Cleaning, For Endoscope

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: 2021-04-16
• Device Publish Date: 2021-02-26

On-Brand Devices [RAPICIDE PA PART A 3X5]

• 40677964021372: 4002405
• 40677964023604: ML02-PTA13