DEVICE: Fukuda Vital Signs Monitor (00860002604404)
Device Identifier (DI) Information
Fukuda Vital Signs Monitor
Fukuda VSM
In Commercial Distribution
FUKUDA DENSHI USA, INC.
Fukuda VSM
In Commercial Distribution
FUKUDA DENSHI USA, INC.
Fukuda Denshi USA, Inc. Spot check Vital Signs Monitor
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K182821 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
fef6b3f1-217e-42e9-a9ae-42a6baedc9e7
November 10, 2021
2
June 05, 2020
November 10, 2021
2
June 05, 2020
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
8003656668
customerservice@fukudaamerica.com
customerservice@fukudaamerica.com