DEVICE: Model 7A (00856233005110)

Device Identifier (DI) Information

Model 7A
7A/Mod 3 Interface cable
In Commercial Distribution
0406
CARDIOCOMMAND, INC.
00856233005110
GS1

1
800214827 *Terms of Use
Interface cable between 7A Stimulator and Model 3 preamplifier.
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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
Transoesophageal external pacemaker 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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FDA Product Code

[?]
Product Code Product Code Name
LPA System, Esophageal Pacing
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P860008 018
P860008 022
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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

bec2048b-1022-4a6c-a715-6fa576a76189
July 06, 2018
3
April 03, 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
Yes
No CLOSE

Customer Contact

[?]
(800) 231-6370
cconley@CardioCommand.com
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