AptiVue™

Basic Information

• Brand Name: AptiVue™
• Primary DI: 05415067030108
• Version / Model: 1014661
• Catalog Number: 1014661
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 149818952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-30
• Public Version: 1
• Public Version Date: 2019-05-08
• Public Version Status: New
• Public Device Record Key: a9945400-5c2f-43f6-badb-77203227a2a1

Device Description

Software Upgrade Kit

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: No
• Has Lot/Batch Number: Yes
• 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
IYO	System, imaging, pulsed echo, ultrasonic	Radiology	892.1560	2
NQQ	SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10980	Cardiac catheterization laboratory computer	A dedicated computer designed to calculate, store, and analyse haemodynamic parameters, and other cardiac-related measurements, based on data from catheterization laboratory monitoring/recording. Such data can be pressure measurements that are converted into useful parameters, e.g., cardiac output, pressure gradients, valve areas, shunt flows, vascular resistance, diastolic filling period or systolic ejection period. The computer may store these values chronologically, along with other physiologic events that occur during the procedure. This GMDN code may reflect old technology; its functions may be performed using off-the-shelf computer ware and dedicated software.	No	Active
47490	Coronary optical coherence tomography system	An assembly of optical and computer-based devices that use a broad-bandwidth light beam for optical coherence tomography (OCT) to provide high-resolution images (e.g., 5 to 40 microns) of the coronary intravasculature. It typically consists of a main operator's console which includes a computer for image storage, keyboard/mouse controls, and a visual display unit (VDU); audio recording facilities; and a printer. The system includes an optical-imaging catheter which is connected to the console for transmission of the images from the intravascular site. The system may be used during interventional cardiology, radiology, or diagnostic angiography.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067030108	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K183320	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry