DEVICE: BRAEBON Leadwire Kit for MediByte (B14086201)

Device Identifier (DI) Information

BRAEBON Leadwire Kit for MediByte
8620
In Commercial Distribution
8620
Braebon Medical Corporation
B14086201
HIBCC

7
251731105 *Terms of Use
Leads for connecting electrodes to a MediByte.
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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
Electrocardiographic lead set, reusable A collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
MNR Ventilatory Effort Recorder
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K061764 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 60 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Length: 24 Inch
Length: 60 Inch
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Device Record Status

ed40f5af-8431-4094-9967-00ab87fe0a86
July 06, 2018
3
September 22, 2016
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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: B14086200 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
613.831.6690
info@braebon.com
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