Men's Liberty Acute

GUDID 10653599000851

Men's Liberty Acute with CathGrip and Towel

BIODERM, INC.

Urinary incontinence penis sheath/port, single-use, non-sterile

• Primary Device ID: 10653599000851
• NIH Device Record Key: f1a00ed4-fe3d-4f5d-a7e5-0c3ee0df035f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Men's Liberty Acute
• Version Model Number: BIO2102611
• Company DUNS: 114773653
• Company Name: BIODERM, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com
• Phone: 800-864-6755
• Email: CustomerCare@BioDermInc.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653599000854 [Primary]
GS1	10653599000851 [Package]; Contains: 00653599000854; Package: box [35 Units]; In Commercial Distribution
HIBCC	M456BIO21026110 [Secondary]

FDA Product Code

• NOA: Device, Paste-On For Incontinence, Non-Sterile

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: 2020-01-14
• Device Publish Date: 2020-01-06