DEVICE: FDK (00859020006116)

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Device Record History
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Device Identifier (DI) Information
FDK
FT-C15Y-V
In Commercial Distribution

Fudakang Industrial Inc.
00859020006116
GS1

1
118811334 *Terms of Use
FDK ARM CUFF BP MONITOR
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
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?
45617 Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DXN System, Measurement, Blood-Pressure, Non-Invasive
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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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
4149a32e-d64c-4555-94cb-ecfdb60fb135
October 23, 2023
9
December 21, 2016
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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
00859020006123 16 00859020006116 In Commercial Distribution Case
10859020006113 4 00859020006116 In Commercial Distribution Inner Pack
30859020006117 24 00859020006116 In Commercial Distribution Case (24)
20859020006110 4 00859020006116 In Commercial Distribution Inner Pack (4)
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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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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