DEVICE: Bio-logic (00382830052467)

Device Identifier (DI) Information

Bio-logic
ABR Standard Insert Earphones 8 ft
In Commercial Distribution
580-SINABR-008
NATUS MEDICAL INCORPORATED
00382830052467
GS1

1
962519208 *Terms of Use
The Bio-logic Insert Earphones are accessories to the Bio-logic ABaer / Navigator Pro Auditory Evoked Response systems. The Bio-logic Insert Earphones devices perform as the means for delivering auditory stimulus to the ears of the patient under test.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
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
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K031352 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Length: 8 Feet
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Device Record Status

c0061f4e-c745-407f-84ce-f091550294c3
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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None
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Production Identifier(s) in UDI

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Customer Contact

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