DEVICE: SJM™ (05414734500920)

Device Identifier (DI) Information

SJM™
3617
In Commercial Distribution
3617
ST. JUDE MEDICAL, INC.
05414734500920
GS1

1
790268031 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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
Electrocardiographic electrode, single-use A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.
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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)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P030054 008
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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
Handling Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -40 and 158 Degrees Fahrenheit
Storage Environment Temperature: between -40 and 158 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

52555872-f93e-4e43-a9ea-4ebb543df2f3
July 06, 2018
3
January 19, 2015
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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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

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