Astroglide Organix Liquid N/A

GUDID 00015594011653

Astroglide® Organix Liquid Personal Lubricant is non-sterile, colorless to slight yellow, 95% organic and water-based personal lubricant. The glycerin and botanicals are certified USDA organic, helping to contribute to an NSF/ANSI 305 certified final product. This product is not a spermicide or contraceptive. Organix Liquid is compatible with natural rubber latex condoms. Organix Liquid is not compatible with polyurethane, or polyisoprene condoms.

BIOFILM, INC

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• Primary Device ID: 00015594011653
• NIH Device Record Key: ef58587d-d041-4f04-b76b-fd93eff1d49d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Astroglide Organix Liquid
• Version Model Number: 015594011653
• Catalog Number: N/A
• Company DUNS: 790780258
• Company Name: BIOFILM, INC
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: true

Customer Support Contacts

• Phone: 1-800-848-5900
• Email: customer.service@biofilm.com
• Phone: 1-800-848-5900
• Email: customer.service@biofilm.com
• Phone: 1-800-848-5900
• Email: customer.service@biofilm.com
• Phone: 1-800-848-5900
• Email: customer.service@biofilm.com
• Phone: 1-800-848-5900
• Email: customer.service@biofilm.com
• Phone: 1-800-848-5900
• Email: customer.service@biofilm.com
• Phone: 1-800-848-5900
• Email: customer.service@biofilm.com
• Phone: 1-800-848-5900
• Email: customer.service@biofilm.com
• Phone: 1-800-848-5900
• Email: customer.service@biofilm.com
• Phone: 1-800-848-5900
• Email: customer.service@biofilm.com
• Phone: 1-800-848-5900
• Email: customer.service@biofilm.com
• Phone: 1-800-848-5900
• Email: customer.service@biofilm.com
• Phone: 1-800-848-5900
• Email: customer.service@biofilm.com
• Phone: 1-800-848-5900
• Email: customer.service@biofilm.com
• Phone: 1-800-848-5900
• Email: customer.service@biofilm.com

Device Dimensions

• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015594011653 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200114

FDA Product Code

• NUC: Lubricant, Personal

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: 2023-06-19
• Device Publish Date: 2023-06-10

On-Brand Devices [Astroglide Organix Liquid]

• 00015594011639: Astroglide® Organix Liquid Personal Lubricant is non-sterile, colorless to slight yellow, 95% o
• 00015594011653: Astroglide® Organix Liquid Personal Lubricant is non-sterile, colorless to slight yellow, 95% o