Intravesical Administration Kit 300025

GUDID 10854913006201

The Intravesical Administration Kit (IVAK) is designed for the convenience of the user for administration of gels or fluids into the urinary tract. The IVAK contains: one (1) Urinary Catheter, 16 Fr (Coude Olive Tip) with Luer lock, one (1) Urinary Catheter, 16 Fr (Straight Tip) with Luer lock, one (1) Luer lock Syringe, 5 mL, four (4) Luer lock Syringe, 20 mL, six (6) CSTD Syringe Adaptors, two (2) CSTD Catheter Luer lock Adaptors, one (1) Polybag

UROGEN PHARMA LTD

Urological surgical procedure kit, non-medicated, single-use

• Primary Device ID: 10854913006201
• NIH Device Record Key: fe2123c1-57ab-4221-9eaf-f3d258df7b1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intravesical Administration Kit
• Version Model Number: IVAK
• Catalog Number: 300025
• Company DUNS: 534155213
• Company Name: UROGEN PHARMA LTD
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-987-6436
• Email: urogen.safety@fortrea.com
• Phone: 1-855-987-6436
• Email: urogen.safety@fortrea.com
• Phone: 1-855-987-6436
• Email: urogen.safety@fortrea.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10854913006201 [Primary]

FDA Product Code

• OHR: Catheter Care Tray

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: 2026-03-23
• Device Publish Date: 2026-03-15

On-Brand Devices [Intravesical Administration Kit ]

• 10854913006171: The Intravesical Administration Kit (IVAK) is designed for the convenience of the user for admin
• 10854913006201: The Intravesical Administration Kit (IVAK) is designed for the convenience of the user for admin