DEVICE: Patient Monitor (06944413814752)

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Device Identifier (DI) Information
Patient Monitor
X8s
In Commercial Distribution

Edan Instruments, Inc.
06944413814752
GS1

1
529173163 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
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No
No
Yes
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GMDN

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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

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Product Code Product Code Name
DQA Oximeter
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
DXN System, Measurement, Blood-Pressure, Non-Invasive
MLD Monitor, St Segment With Alarm
FLL Thermometer, Electronic, Clinical
DSK Computer, Blood-Pressure
DSB Plethysmograph, Impedance
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
DSI Detector And Alarm, Arrhythmia
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization
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No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
9a74ecd9-0d90-441f-a6ec-5fc352014107
November 10, 2021
2
September 30, 2020
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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
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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