DEVICE: Amplivox (05060488901030)

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Device Identifier (DI) Information

Amplivox
Model 240

AMPLIVOX LIMITED
05060488901030
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Pure-tone audiometer An electroacoustic device that generates tones throughout the audible range (usually at each octave between 125 Hz and 8 kHz) at amplitudes related to the expected thresholds for a normally hearing person, and presents them to a patient, typically one ear at a time with headphones, to evaluate hearing. The difference between the patient threshold and the normal (i.e., the hearing loss) is typically recorded on an audiogram chart in decibels. The device may be equipped with a bone vibrator for direct inner-ear stimulation to corroborate hearing loss. A masking tone system is necessary for testing if there is a large difference in hearing between the ears.
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FDA Product Code

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Product Code Product Code Name
EWO Audiometer
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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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

Not in Commercial Distribution
September 24, 2016
November 10, 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
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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