Merit Medical®

Basic Information

• Brand Name: Merit Medical®
• Primary DI: 00884450475607
• Version / Model: 00884450475607
• Catalog Number: K09-12181D
• Company Name: Merit Medical Systems, Inc.
• Labeler DUNS: 184763290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-13
• Public Version: 2
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: e1d08edc-c50e-4564-9f2b-7d311df050df

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
OEZ	Cardiovascular procedure kit	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47258	Contrast medium injection system administration set	A collection of noninvasive devices designed to conduct fluids between a contrast medium injection system and a patient catheter for the delivery of a contrast medium and/or saline solution to a patient undergoing a diagnostic imaging procedure. It consists of tubing with switches/valves and connectors to syringes/fluid/contrast medium injection system, and possibly a pressure transducer; it is typically made of plastic materials. This is a disposable device which may serve multiple patients before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10884450475604	GS1		6	In Commercial Distribution
Primary	00884450475607	GS1
Package	20884450475601	GS1		2	In Commercial Distribution