Cysto-Aid: Urine Collection Device 901004

GUDID 30815112021697

Urine Collection Device

Bracco Diagnostics Inc.

Non-wearable adult urine collection bag, open-ended

• Primary Device ID: 30815112021697
• NIH Device Record Key: a47f5433-cc48-44b0-8c88-e8d18c88b49e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cysto-Aid: Urine Collection Device
• Version Model Number: 901004
• Catalog Number: 901004
• Company DUNS: 849234661
• Company Name: Bracco Diagnostics 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815112021693 [Primary]
GS1	30815112021697 [Package]; Contains: 10815112021693; Package: Box [25 Units]; In Commercial Distribution

FDA Product Code

• FNP: Urinal

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: 2026-01-19
• Device Publish Date: 2026-01-09

Devices Manufactured by Bracco Diagnostics Inc.

• 30815112021697 - Cysto-Aid: Urine Collection Device: 2026-01-19Urine Collection Device
• 30815112021697 - Cysto-Aid: Urine Collection Device: 2026-01-19 Urine Collection Device
• 30815112021444 - Mixing Container: 2026-01-19 Mixing Container
• 30815112021475 - Transpec Specimen Radiography Device: 2026-01-19 Transpec Specimen Radiography Device
• 30815112021482 - Transpec: 2026-01-19 Transpec Specimen Radiography Device
• 30815112021505 - E-Z-Mark: 2026-01-19 Marker
• 30815112021543 - HeartSee Cardiac PET Processing Software: 2025-08-04 Cardiac PET Processing Software
• 30815112021703 - Two Tank Shuttle Valve System: 2025-07-08 Two Tank Shuttle Valve System
• 30815112021710 - DIN 477 High Pressure Hose for CO2: 2025-07-08 DIN Connector