MEDRAD® Mark 7 Arterion Injection System

Basic Information

• Brand Name: MEDRAD® Mark 7 Arterion Injection System
• Primary DI: 00616258026312
• Version / Model: ART 700
• Catalog Number: ART 700
• Company Name: Bayer Medical Care Inc.
• Labeler DUNS: 049673973
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-06
• Public Version: 1
• Public Version Date: 2024-05-14
• Public Version Status: New
• Public Device Record Key: 1cd9063e-dc2b-4f1b-9e90-8f64a8a48605
• Distribution End Date: 9999-12-31

Device Description

MARK 7 ARTERION,PKG,BASE SYSTEM,RU,LR (88351614)

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXT	Injector And Syringe, Angiographic	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57997	Angiography contrast medium injection system, line-powered, mobile	An assembly of devices designed to inject contrast media through a small catheter and into the vascular system for angiographic procedures (e.g., examination of the coronary and renal arteries, and great vessels and vasculature of the heart, brain, abdominal organs, and extremities). It consists of mains electricity (AC-powered) electromechanical injectors (electric motor connected to a jackscrew that moves a syringe piston) with syringes capable of delivering media with the pressure, flow range, and volume required for angiographic studies, and is mobile (e.g., on a wheeled pedestal). Some types can synchronize media delivery with the electrocardiographic cycle and/or the x-ray generator.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00616258026312	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K113133	000

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 57 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 5 – 100 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius