DEVICE: Fukuda Vital Signs Monitor (00860002604404)

Device Identifier (DI) Information

Fukuda Vital Signs Monitor
Fukuda VSM
In Commercial Distribution

FUKUDA DENSHI USA, INC.
00860002604404
GS1

1
199040556 *Terms of Use
Fukuda Denshi USA, Inc. Spot check Vital Signs Monitor
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Device Characteristics

MR Unsafe
No
Yes
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?
33586 General-purpose multi-parameter bedside monitor
An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K182821 000
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

fef6b3f1-217e-42e9-a9ae-42a6baedc9e7
November 10, 2021
2
June 05, 2020
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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

[?]
8003656668
customerservice@fukudaamerica.com
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