DEVICE: Tapcath (00856233005042)

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Device Identifier (DI) Information

Tapcath
205, single pack
180
CARDIOCOMMAND, INC.
00856233005042
GS1
1
5 French esophageal bipolar pacing and recording catheter, (single unit package).
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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 pacing lead A flexible wire with an electrode, insulated with non-conductive material except at its ends, that serves as an electrical conductor to regulate cardiac pacing, with one end connected to an external temporary pacemaker and the other end (electrode) applied through the oesophagus to the heart. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
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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
Catheter Gauge: 5 French
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Device Status

In Commercial Distribution
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
10856233005049 5 00856233005042 In Commercial Distribution Box of 5 units
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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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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