DEVICE: Merlin¿@home™ (05414734507011)

Device Identifier (DI) Information

Merlin¿@home™
EX1151
In Commercial Distribution
EX1151
ST. JUDE MEDICAL, INC.
05414734507011
GS1

1
790268031 *Terms of Use
Wireless USB Adapter for use with Merlin@home Transmitter
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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
External pacemaker analyser An electronic instrument designed to test an external pacemaker to ensure compliance with performance specifications. The device connects to the output of the pacemaker to test any or all of the pulse generator's parameters including pulse duration, pulse amplitude, pulse rate, and sensing threshold. The device may be used to test the function of an external pacemaker periodically, after repair, or for training purposes.
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FDA Product Code

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Product Code Product Code Name
NVZ Pulse generator, permanent, implantable
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P910023 173
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Sterilization

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

[?]
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

5c2177cd-bb06-4a32-b25c-4238eb969e0e
July 06, 2018
3
November 18, 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

[?]
Yes
Yes
No
Yes
No CLOSE

Customer Contact

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