Merlin™

Basic Information

• Brand Name: Merlin™
• Primary DI: 05415067037121
• Version / Model: MER3400
• Catalog Number: MER3400
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 149818952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-29
• Public Version: 1
• Public Version Date: 2022-09-06
• Public Version Status: New
• Public Device Record Key: f7ce496f-7cec-468d-b5c8-ceff05f105fe

Device Description

Software for Merlin 2.0

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
LWS	Implantable cardioverter defibrillator (non-CRT)	Unknown		3
LWO	Pulse-generator, single chamber, sensor driven, implantable	Unknown		3
DXY	implantable pacemaker Pulse-generator	Cardiovascular	870.3610	3
NKE	Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)	Unknown		3
NIK	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)	Unknown		3
OSR	Pacemaker/icd/crt non-implanted components	Unknown		3
LWP	Implantable pulse generator, pacemaker (non-CRT)	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61680	Implantable cardiac device management application software	An application software program intended to be used in the management of an implantable cardiac device (e.g., monitor, pulse generator, pacemaker, defibrillator) by enabling computer-assisted functionality typically in one or more of the following areas: device programming; device function analysis; data extraction, storage, analysis and/or transfer; and clinical consultation/intervention planning. Depending on the functionality, it can run on dedicated hardware, an off-the-shelf computer (e.g., tablet, smartphone), or web-based servers.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067037121	GS1

Customer Contacts

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