Fluid Administration Set

Basic Information

• Brand Name: Fluid Administration Set
• Primary DI: 10815112020016
• Version / Model: 000475
• Catalog Number: 000475
• Company Name: BRACCO DIAGNOSTICS INC
• Labeler DUNS: 849234661
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 3
• Public Version Date: 2023-07-28
• Public Version Status: Update
• Public Device Record Key: 471ea654-56d6-4225-8e72-10857d7f6f45
• Distribution End Date: 2023-07-27

Device Description

Large Bore Tubing Administration Set

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EYN	Tray, Irrigation, Sterile	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44685	Radiographic procedure tubing	A flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10815112020016	GS1
Package	20815112020013	GS1	Box	10	Not in Commercial Distribution	2023-07-27
Package	30815115050010	GS1	Box	80	Not in Commercial Distribution	2023-07-27

Customer Contacts

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