DEVICE: EP Connect (00856233005080)
Device Identifier (DI) Information
EP Connect
Tapcath
In Commercial Distribution
8031-0001
CARDIOCOMMAND, INC.
Tapcath
In Commercial Distribution
8031-0001
CARDIOCOMMAND, INC.
A 10 ft. cable that connects Tapcath catheter products to ECG recorders using a modular to pin connector. .
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
47483 | Electrocardiographic lead/catheter adaptor |
A small, sterile, connecting device that enables a mechanical union between an in situ cardiac catheter [e.g., an electrophysiology (EP) diagnostic catheter] and an electrocardiograph (ECG) cable/lead for transmission of heart signals to an ECG machine. This device allows the connection of the otherwise incompatible connectors of the cardiac catheter to a standard ECG cable/lead or a cable/lead of different manufacture. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P860008 | 017 |
P860008 | 019 |
P860008 | 020 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3d2f9cd7-9438-4e12-a3f0-657091a9d0fd
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 |
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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
[?]
(800) 231-6370
cconley@CardiCommand.com
cconley@CardiCommand.com