Astroglide Ultra Gentle Gel N/A

GUDID 00015594011813

Astroglide Ultra Gentle Gel is a personal lubricant for penile, vaginal, and/or anal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

BIOFILM, INC

Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant

• Primary Device ID: 00015594011813
• NIH Device Record Key: 0454dec1-0103-494d-b4fa-be503d222584
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Astroglide Ultra Gentle Gel
• Version Model Number: 015594011813
• 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

• Weight: 2.5 Gram
• Weight: 2.5 Gram
• Weight: 2.5 Gram
• Weight: 2.5 Gram
• Weight: 2.5 Gram
• Weight: 2.5 Gram
• Weight: 2.5 Gram
• Weight: 2.5 Gram
• Weight: 2.5 Gram
• Weight: 2.5 Gram
• Weight: 2.5 Gram
• Weight: 2.5 Gram
• Weight: 2.5 Gram
• Weight: 2.5 Gram
• Weight: 2.5 Gram

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	00015594011813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220355

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 Ultra Gentle Gel]

• 00015594011035: Astroglide Ultra Gentle Gel is a personal lubricant for penile, vaginal, and/or anal applicatio
• 00015594011813: Astroglide Ultra Gentle Gel is a personal lubricant for penile, vaginal, and/or anal applicatio