DEVICE: Bio-logic (00382830001090)

Device Identifier (DI) Information

Bio-logic
ABaer
In Commercial Distribution
580-ABAER2
NATUS MEDICAL INCORPORATED
00382830001090
GS1

1
962519208 *Terms of Use
The ABaer Hearing Screening System performs automated objective hearing screening utilizing auditory brainstem responses (ABR) and/or otoacoustic emissions (OAE).
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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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.
Auditory stimulator A mains electricity (AC-powered) device that applies sound stimuli (e.g., pure tones, speech) to a patient's acoustic system. It is typically used as a component of several types of devices such as audiometers, auditory evoked-potential recording systems, and auditory function screening devices.
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
K112247 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 15 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Handling Environment Temperature: between 15 and 40 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Weight: 400 Gram
Depth: 1.7 Inch
Width: 4.0 Inch
Height: 7.6 Inch
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Device Record Status

9fdabf03-2b54-4205-bf77-e0d73dc252f0
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
No
No
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Customer Contact

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