Renalin

GUDID 30677964021825

MEDIVATORS INC.

Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use Organic peroxy acid device sterilant, single-use

• Primary Device ID: 30677964021825
• NIH Device Record Key: 0f46d342-348f-4fb6-83de-c3fd34d8366a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renalin
• Version Model Number: 78404-000
• 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

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00677964021824 [Primary]
GS1	30677964021825 [Package]; Contains: 00677964021824; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941439

FDA Product Code

• LRJ: Disinfectant, Medical Devices

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: 2018-03-29
• Device Publish Date: 2018-02-26

On-Brand Devices [Renalin]

• 30677964021825: 78404-000
• 30677964000288: 78336-000