DEVICE: Merlin™ (05414734502078)

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Device Identifier (DI) Information

Merlin™
Antenna
3638
ST. JUDE MEDICAL, INC.
05414734502078
GS1
1
Merlin™ Antenna
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Cardiac pulse generator programmer An external device intended to enable a healthcare professional in a clinical setting to noninvasively change the settings of, and extract data from, an implanted cardiac pulse generator (e.g., pacemaker, pacemaker/defibrillator). It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software.
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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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Sterilization

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

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Storage and Handling
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Handling Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Temperature: between -40 and 158 Degrees Fahrenheit
Handling Environment Temperature: between -40 and 158 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
February 03, 2017

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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