Renalin Residual Test Strips

GUDID 10677964007979

MEDIVATORS INC.

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• Primary Device ID: 10677964007979
• NIH Device Record Key: 05996ab8-04cf-481f-8141-7e33032491be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renalin Residual Test Strips
• Version Model Number: 78198-000
• 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	00677964007972 [Unit of Use]
GS1	10677964007979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K830575

FDA Product Code

• LIF: Dialyzer Reprocessing System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-11-02
• Device Publish Date: 2018-07-09

On-Brand Devices [Renalin Residual Test Strips]

• 10677964007979: 78198-000
• 00677964007972: 78198-000