DEVICE: Model 3 (00856233005196)
Device Identifier (DI) Information
Model 3
Re-manufactured, unpackaged
In Commercial Distribution
0104-9999
CARDIOCOMMAND, INC.
Re-manufactured, unpackaged
In Commercial Distribution
0104-9999
CARDIOCOMMAND, INC.
Amplification and signal processing module designed to interface with CardioCommand esophageal catheters to enable recording of esophageal cardiac signals; re-manufactured, (unpackaged unit).
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? |
---|---|---|---|---|
36719 | Electrocardiographic signal amplifier |
An electrical device that amplifies the signal level and provides impedance matching between two or more medical devices when bioelectrical signals from the heart are transmitted between them.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LPA | System, Esophageal Pacing |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P860008 | 018 |
P860008 | 022 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Atmospheric Pressure: between 500 and 1060 millibar |
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity |
Handling Environment Temperature: between 40 and 158 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
87cf5698-406e-45a7-936e-6b56dc0d74ef
July 06, 2018
3
April 03, 2015
July 06, 2018
3
April 03, 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 |
---|---|---|---|---|---|
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
[?]
(800) 231-6370
cconley@CardioCommand.com
cconley@CardioCommand.com