DEVICE: Earlens Charger (00850013007035)

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Device Record History
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Device Identifier (DI) Information
Earlens Charger
CHEL101
In Commercial Distribution
CHEL101
EARLENS CORPORATION
00850013007035
GS1

1
611658795 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
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?
17115 Noninvasive device battery charger
An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PLK Tympanic Membrane Direct Contact Hearing Aid
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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

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Storage and Handling
Handling Environment Atmospheric Pressure: between 525 and 795 Millimeter of Mercury
Handling Environment Humidity: between 0 and 93 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 55 Degrees Celsius
Storage Environment Atmospheric Pressure: between 525 and 795 Millimeter of Mercury
Storage Environment Humidity: between 0 and 93 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 55 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
918b1e8c-34fe-4491-a6eb-fa426c63a9d7
May 07, 2020
7
September 24, 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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