AVEIR™

Basic Information

• Brand Name: AVEIR™
• Primary DI: 05415067046475
• Version / Model: LSRM01
• Catalog Number: LSRM01
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 790268031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-11
• Public Version: 1
• Public Version Date: 2024-12-19
• Public Version Status: New
• Public Device Record Key: 5ff6e1af-6336-43de-aaf0-7ce5ba45c693

Device Description

Patient Transmitter

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: MR Unsafe
• 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
PNJ	Leadless pacemaker	Cardiovascular	870.3610	3

GMDN Terms

Code	Name	Definition	Implantable	Status
47269	Transtelephonic implantable pacemaker analysis system	An assembly of devices designed to analyse the performance of an implanted pacemaker based on electrocardiographic measurements that can be monitored transtelephonically. It typically includes a computer-based pacemaker analyser, a 12-lead electrocardiograph (ECG), and a transtelephonic receiver and/or transmitter. It provides data taken directly from the patient (e.g., ECG electrodes are applied to the patient and a test magnet is placed over the pacemaker to activate it) or a pacemaker programmer. Signals are sent to the receiver where pacemaker function information is displayed. This system may also include a database that collects and stores patient data.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067046475	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P150035	007

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 41 – 104 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 41 – 104 Degrees Fahrenheit