Aveir™

Basic Information

• Brand Name: Aveir™
• Primary DI: 05415067034496
• Version / Model: LSCR111
• Catalog Number: LSCR111
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 790268031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-03
• Public Version: 2
• Public Version Date: 2023-10-02
• Public Version Status: Update
• Public Device Record Key: 8032bef1-9fa8-4328-adbf-0a2d24e10028

Device Description

Retrieval Catheter

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
MMX	Device, percutaneous retrieval	Cardiovascular	870.5150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60881	Intracardiac pacemaker extraction catheter	A sterile, steerable flexible tube with a distal snaring mechanism intended to be introduced into the right ventricle of the heart, via transcutaneous peripheral venous access (e.g., femoral vein), to remove an implanted intracardiac pacemaker; it may also be used to remove an intracardiac pacemaker that has migrated to the peripheral vasculature. It typically has control handle with flush ports, and a single- or multi-looped snare which emerges from the distal tip of the catheter; it may include devices dedicated to catheter introduction (e.g., introducer, guidewire). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067034496	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K213494	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	6.8000	Millimeter
Length	105.0000	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry. Keep away from sunlight.