DEVICE: CONTEC (06945040101499)
Device Identifier (DI) Information
CONTEC
TLC5007
In Commercial Distribution
Contec Medical Systems Co., Ltd.
TLC5007
In Commercial Distribution
Contec Medical Systems Co., Ltd.
Dynamic ECG Systems
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
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No | |
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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? |
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35162 | Electrocardiographic ambulatory recorder |
An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K101273 | 000 |
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
99dd4a09-5c34-4fc7-a350-e0da81bbb1c6
November 08, 2019
4
September 24, 2016
November 08, 2019
4
September 24, 2016
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
[?]
No Customer Contact currently defined