DEVICE: Smart Trace Electrodes .060 in (B0361015663)

Device Identifier (DI) Information

Smart Trace Electrodes .060 in
1015663
In Commercial Distribution
1015663
CIRCADIANCE, LLC
B0361015663
HIBCC

1
012721295 *Terms of Use
Smart Trace Electrodes .060 in., 10 Sets of 3
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Neonatal electrocardiographic electrode A non-sterile electrical conductor applied to a neonatal patient to transmit electrical signals from the body surface to a data measuring/display device (typicaly an electrocardiograph, patient monitor, or patient monitoring system) to produce an electrocardiogram (ECG). This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DRX Electrode, Electrocardiograph
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 5 and 27 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

7cf64503-1e16-4ede-ad14-a72a76f4a5d8
March 29, 2018
2
September 26, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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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
Yes
No
No CLOSE

Customer Contact

[?]
1-888-825-9640
info@circadiance.com
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