Merit Medical®

Basic Information

• Brand Name: Merit Medical®
• Primary DI: 00884450419892
• Version / Model: 00884450419892
• Catalog Number: K08-03201
• Company Name: Merit Medical Systems, Inc.
• Labeler DUNS: 184763290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-23
• Public Version: 1
• Public Version Date: 2020-01-31
• Public Version Status: New
• Public Device Record Key: 9da1f4f3-1484-4ede-97e1-9eafb2e365fd

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OJA	Intravenous extension tubing set	General Hospital	880.5440	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	20884450419896	GS1		4	In Commercial Distribution
Package	10884450419899	GS1		15	In Commercial Distribution
Primary	00884450419892	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Tubing Length (in/cm)-72" (183 cm)