DEVICE: BRAEBON Leadwire Kit for MediByte (B14086201)

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Device Identifier (DI) Information

BRAEBON Leadwire Kit for MediByte
8620
8620
Braebon Medical Corporation
B14086201
HIBCC
7
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, reusable A device 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 may be designed as: 1) an insulated metal wire(s) with a permanently attached electrode; or 2) an insulated metal wire(s) with a detachable electrode. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
MNR Ventilatory Effort Recorder
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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 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 Status

In Commercial Distribution
September 22, 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: 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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