DEVICE: Merlin@home™ (05415067034809)

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Device Record History
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Device Identifier (DI) Information
Merlin@home™
EX1150W
In Commercial Distribution
EX1150W
ST. JUDE MEDICAL, INC.
05415067034809
GS1

1
790268031 *Terms of Use
Transmitter
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OSR Pacemaker/icd/crt non-implanted components
NKE Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
LWS Implantable cardioverter defibrillator (non-CRT)
LWO Pulse-generator, single chamber, sensor driven, implantable
DXY implantable pacemaker Pulse-generator
LWP Implantable pulse generator, pacemaker (non-CRT)
NIK Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
NVZ Pulse generator, permanent, implantable
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 50 and 104 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Temperature: between -13 and 158 Degrees Fahrenheit
Handling Environment Temperature: between -25 and 70 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
b1b9b82a-45ee-4b13-81d3-0f81aac6463f
March 03, 2025
2
November 13, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
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