DEVICE: GN Otometrics A/S (05713315004124)

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Device Identifier (DI) Information

GN Otometrics A/S
"AirCal Caloric Stimulator, Extended

Gn Otometrics A/S
05713315004124
GS1
1
No description.
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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
Caloric vestibular-stimulation system An assembly of devices intended to apply heat stimuli in the form of a stream of air or water into the ear canal. It typically consists of an irrigation system that includes a pump, valves, heaters and regulators to control the rate of flow and temperature of the medium. The stimulation of the semicircular canal produces involuntary eye movements (nystagmus) which are measured using a nystagmograph. It is used for vestibular function testing for assessing the patient's balance system. This device is typically used in an ear/nose/throat (ENT) department.
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FDA Product Code

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Product Code Product Code Name
KHH Stimulator, Caloric-Air
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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
No Device Sizes
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Device Status

In Commercial Distribution
September 19, 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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No CLOSE

Customer Contact

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No Customer Contact currently defined
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