DEVICE: Model 7A (00856233005172)
Device Identifier (DI) Information
Model 7A
Re-manufactured, unpackaged
In Commercial Distribution
0101-9999
CARDIOCOMMAND, INC.
Re-manufactured, unpackaged
In Commercial Distribution
0101-9999
CARDIOCOMMAND, INC.
Transesophageal cardiac stimulator intended for the temporary pacing of the atrium and designed for use with the Model 3 Preamplifier for the 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? |
---|---|---|---|---|
36046 | External pacemaker, transoesophageal pacing |
A device designed to generate electrical cardiac pacing impulses from an external pulse generator (EPG), located outside the body, and transmit them to the heart via its leads that are placed in the oesophagus. The device is used for temporary stimulation of the heart.
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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
ff880721-c112-402e-9eb8-bb822df1959b
October 05, 2018
4
April 03, 2015
October 05, 2018
4
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