DEVICE: Xavant Technology (06009880396160)

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Device Identifier (DI) Information

Xavant Technology
NMBA Cable with accelerometer (3.5m)
XT-45015A
XAVANT TECHNOLOGY (PTY) LTD
06009880396160
GS1
1
Neuromuscular blocking agent monitoring cable (3.5 m) with three dimensional acceleromyography.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
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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
Diagnostic peripheral nerve electrical stimulation system An assembly of devices designed to apply electrical stimuli in one peripheral region of the body while the response is monitored in another peripheral region. It typically consists of external electrodes (e.g., hand-held bipolar or ring electrodes) or needle electrodes and a pulse generator. It is used for the stimulation of a peripheral nerve or muscle in motor-nerve conduction studies (e.g., the posterior tibial nerve), and/or in sensory-nerve conduction studies (e.g., the ulnar nerve) performed during clinical electrophysiology (EP) assessments.
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FDA Product Code

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Product Code Product Code Name
BXN Stimulator, Nerve, Battery-Powered
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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: less than 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 50 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
January 10, 2017

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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
16009880396167 1 06009880396160 In Commercial Distribution Box
26009880396164 2 16009880396167 In Commercial Distribution Box
36009880396161 5 26009880396164 In Commercial Distribution Box
46009880396168 2 36009880396161 In Commercial Distribution Box
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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)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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