Mariner

Basic Information

• Brand Name: Mariner
• Primary DI: H787117322010
• Version / Model: 11732201
• Company Name: ANGIODYNAMICS, INC.
• Labeler DUNS: 079105071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 4
• Public Version Date: 2018-12-19
• Public Version Status: Update
• Public Device Record Key: fc42756f-7e9c-4759-9f09-518ebbd434ab

Device Description

Mariner Hydrophilic Coated Angiographic Catheter, Omni Flush, Non-Braided

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
DQO	CATHETER, INTRAVASCULAR, DIAGNOSTIC	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10688	Angiographic catheter, single-use	A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H787117322015	HIBCC	BOX	10	In Commercial Distribution
Primary	H787117322010	HIBCC
Secondary	15051684002820	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K112452	000
K161596	000
K173762	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	5	French
Length	65	Centimeter
Pressure	1050	Pound per Square Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 27 Degrees Celsius