DEVICE: Merlin.net (05414734509732)

Device Identifier (DI) Information

Merlin.net
MN5000
In Commercial Distribution
MN5000
ST. JUDE MEDICAL, INC.
05414734509732
GS1

1
790268031 *Terms of Use
Patient Interactive Website
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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Product Code Product Code Name
NIK Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
OSR Pacemaker/icd/crt non-implanted components
NKE Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
LWP Implantable pulse generator, pacemaker (non-CRT)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P030035 129
P030035 139
P030035 140
P030054 278
P030054 292
P030054 294
P140033 000
P880086 251
P880086 261
P880086 262
P910023 348
P910023 362
P910023 364
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

54a47eb9-bfeb-4735-816b-d0fb3e21d153
July 06, 2018
3
May 04, 2016
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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

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

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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
No
No
No
No CLOSE

Customer Contact

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