DEVICE: Lutech (B299760NICP0)

Device Identifier (DI) Information

Lutech
Datalys 760
In Commercial Distribution

LUTECH INDUSTRIES INC
B299760NICP0
HIBCC

1
078698036 *Terms of Use
Multi-parameter patient monitor. 760-N-IC-P
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
36872 Multiple vital physiological parameter monitoring system, clinical
An assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DPS Electrocardiograph
FLL Thermometer, Electronic, Clinical
DQA Oximeter
MWI Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
DXN System, Measurement, Blood-Pressure, Non-Invasive
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K150691 000
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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

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Size Type Text
No Device Sizes
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Device Record Status

c1813ef9-bd1c-4fe3-bc9e-8c210ecaa1ae
November 10, 2021
5
September 12, 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
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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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