Merlin¿@home™ EX1151

GUDID 05414734507011

Wireless USB Adapter for use with Merlin@home Transmitter

ST. JUDE MEDICAL, INC.

External pacemaker analyser Transtelephonic implantable pacemaker analysis system Transtelephonic implantable pacemaker analysis system Transtelephonic implantable pacemaker analysis system Transtelephonic implantable pacemaker analysis system Transtelephonic implantable pacemaker analysis system Transtelephonic implantable pacemaker analysis system Transtelephonic implantable pacemaker analysis system Transtelephonic implantable pacemaker analysis system Transtelephonic implantable pacemaker analysis system Transtelephonic implantable pacemaker analysis system Transtelephonic implantable pacemaker analysis system Transtelephonic implantable pacemaker analysis system Transtelephonic implantable pacemaker analysis system Transtelephonic implantable pacemaker analysis system Transtelephonic implantable pacemaker analysis system
Primary Device ID05414734507011
NIH Device Record Key5c2177cd-bb06-4a32-b25c-4238eb969e0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMerlin¿@home™
Version Model NumberEX1151
Catalog NumberEX1151
Company DUNS790268031
Company NameST. JUDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734507011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVZPulse generator, permanent, implantable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-04
Device Publish Date2016-11-18

Devices Manufactured by ST. JUDE MEDICAL, INC.

05415067049414 - Entrant™2024-05-03 VR Implantable Cardioverter Defibrillator
05415067049421 - Gallant™2024-05-03 VR Implantable Cardioverter Defibrillator
05415067049469 - Entrant™2024-05-03 DR Implantable Cardioverter Defibrillator
05415067049476 - Gallant™2024-05-03 DR Implantable Cardioverter Defibrillator
05415067049513 - Entrant™2024-05-03 HF Cardiac Resynchronization Therapy Defibrillator
05415067049520 - Gallant™2024-05-03 HF Cardiac Resynchronization Therapy Defibrillator
05415067047700 - TriClip™2024-04-22 G4 Delivery System
05415067047724 - TriClip™2024-04-22 G4 Delivery System

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.