MEDRAD® Centargo Patient Line

Basic Information

• Brand Name: MEDRAD® Centargo Patient Line
• Primary DI: 09345390002656
• Version / Model: CENT-PL
• Catalog Number: CENT-PL
• Company Name: IMAXEON PTY LTD
• Labeler DUNS: 740733993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-28
• Public Version: 1
• Public Version Date: 2025-04-07
• Public Version Status: New
• Public Device Record Key: 8e5b2fa4-c58c-45c6-bff2-4f5111434ea1
• Distribution End Date: 9999-12-31

Device Description

ASSY,TUBE SET,PATIENT LINE,CENTARGO,US

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
DXT	Injector And Syringe, Angiographic	Cardiovascular	870.1650	2
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	870.1650	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
Package	49345390002654	GS1	Box	50	In Commercial Distribution	9999-12-31
Primary	09345390002656	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity