Cysto-Aid: Urine Collection Device

Basic Information

• Brand Name: Cysto-Aid: Urine Collection Device
• Primary DI: 10815112021693
• Version / Model: 901004
• Catalog Number: 901004
• Company Name: Bracco Diagnostics Inc.
• Labeler DUNS: 849234661
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-09
• Public Version: 1
• Public Version Date: 2026-01-19
• Public Version Status: New
• Public Device Record Key: a47f5433-cc48-44b0-8c88-e8d18c88b49e

Device Description

Urine Collection Device

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FNP	Urinal	General Hospital	880.6730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58921	Non-wearable adult urine collection bag, open-ended	A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30815112021697	GS1	Box	25	In Commercial Distribution
Primary	10815112021693	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]