DEVICE: Bio-logic (00382830053181)

Device Identifier (DI) Information

Bio-logic
Navigator Pro
In Commercial Distribution
580-NAVPR2
NATUS MEDICAL INCORPORATED
00382830053181
GS1

1
962519208 *Terms of Use
The Bio-logic Navigator Pro AEP system is indicated for use in the recording and display of human physiological data, for auditory screening purposes and to assist in determining possible auditory and hearing disorders.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Evoked-potential audiometer An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.
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FDA Product Code

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Product Code Product Code Name
GWJ Stimulator, Auditory, Evoked Response
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K031009 000
K073626 000
K083371 000
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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 25 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Handling Environment Humidity: between 25 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 35 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

426ab753-ce0e-44d0-ac9c-91282d1f806e
July 06, 2018
3
December 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: 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
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No
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Customer Contact

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1-800-303-0306
BLSC_Hearing_Support@natus.com
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