DEVICE: MediGuide™ (05415067004307)
Device Identifier (DI) Information
MediGuide™
Technology
In Commercial Distribution
H700430
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution
H700430
ST. JUDE MEDICAL, INC.
No description.
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. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
46265 | Cardiac mapping system |
An assembly of devices designed to measure, process, and store electronic data for the interpretation of cardiac physiological parameters received from the output of connected measuring devices (e.g., body surface or intracardiac electrocardiograph (ECG) sensors, transducers, and catheters). The measurements can be compared to pre-established diagnostic criteria for parameters such as cardiac blood flow, electrical conduction, or heart chamber geometry. It typically consists of dedicated workstation, hardware and software that display real-time, three-dimensional (3-D) cardiac maps (e.g., electrical propagation, electrical potential, and cardiac chamber geometry maps), and a catheter.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K120301 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between -13 and 158 Degrees Fahrenheit |
Handling Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Special Storage Condition, Specify: Keep Dry. |
Storage Environment Temperature: between -13 and 158 Degrees Fahrenheit |
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Handling Environment Temperature: between -25 and 70 Degrees Celsius |
Storage Environment Temperature: between -25 and 70 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
92aad75a-174b-4f96-afd6-4da61dd6b625
July 22, 2019
3
August 21, 2015
July 22, 2019
3
August 21, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(855)478-5833
customerservice@sjm.com
customerservice@sjm.com