Actril Cold Sterilant

GUDID 40677964016736

MEDIVATORS INC.

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• Primary Device ID: 40677964016736
• NIH Device Record Key: de0caa91-b19f-40f3-bd4a-aa9391811c61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Actril Cold Sterilant
• Version Model Number: 4001944
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	40677964016729 [Primary]
GS1	40677964016736 [Package]; Contains: 40677964016729; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K861730

FDA Product Code

• FKQ: System, Dialysate Delivery, Central Multiple Patient

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: 2020-04-01
• Device Publish Date: 2020-03-24

On-Brand Devices [Actril Cold Sterilant]

• 30677964000295: 78270-000
• 30677964000240: 78337-000
• 40677964016736: 4001944