DEVICE: SJM™ (05414734506373)

Device Identifier (DI) Information

SJM™
EX3000
In Commercial Distribution
EX3000
ST. JUDE MEDICAL, INC.
05414734506373
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© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
35035 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.
Active false
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FDA Product Code

[?]
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 [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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

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

[?]
Size Type Text
No Device Sizes
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Device Record Status

5de2980b-11cc-4646-bef4-553992ffcb28
February 04, 2019
4
January 19, 2015
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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

[?]
Yes
No
No
No
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Customer Contact

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