DEVICE: Edge Mini-Dock (00841517110369)

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Device Record History
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Device Identifier (DI) Information
Edge Mini-Dock
P15078-43
In Commercial Distribution
P15078
FUJIFILM SONOSITE, INC.
00841517110369
GS1

1
014438860 *Terms of Use
DIAGNOSTIC ULTRASOUND ACCAESSORY
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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
ITX Transducer, Ultrasonic, Diagnostic
IYN System, Imaging, Pulsed Doppler, Ultrasonic
IYO System, Imaging, Pulsed Echo, Ultrasonic
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K113156 000
K133454 000
No CLOSE

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

[?]
Storage and Handling
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -35 and 65 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -35 and 65 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
437a5f78-7886-4534-83cf-e1636735fba2
June 18, 2024
1
June 10, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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