DEVICE: Hearing Test Feature (HTF) (00195949149948)

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Device Identifier (DI) Information
Hearing Test Feature (HTF)
Feature version 1.X
In Commercial Distribution

APPLE INC.
00195949149948
GS1

1
060704780 *Terms of Use
Hearing Test Feature iOS (1.X)
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46964 Self-testing tone audiometer
A battery-powered electroacoustic device that is designed for self-testing by the user to qualitatively evaluate hearing acuity by presenting a series of tones at a fixed level. It is placed over the user's ear and a microprocessor [central processing unit (CPU)] in the device automatically produces a range of tones at pre-set decibel (dB) levels. If the user cannot hear all of the tones then this may be an indication of diminished hearing acuity and the need for formal audiological assessment. This device is available [non-prescription] over-the-counter (OTC) and is typically used in the home or a general practitioner's office.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EWO Audiometer
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

[?]
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 Record Status
3d1f8168-830e-41d3-a932-9ab68ef06bc4
October 29, 2024
1
October 21, 2024
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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