DEVICE: Lutech (B299760LICP0)

Device Identifier (DI) Information

Lutech
Datalys 760
In Commercial Distribution

LUTECH INDUSTRIES INC
B299760LICP0
HIBCC

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

Labeling does not contain MRI Safety Information
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No
No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Transportable physiologic monitoring system An assembly of battery-powered devices designed for continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of a patient in transit [e.g., during transport to, between, or within a hospital(s)]. It typically includes a recorder, amplifier, display monitor, and patient leads/attachments; it may also be used by the bedside where it is normally connected to the mains electricity.
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FDA Product Code

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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

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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

15c6bf6e-30a3-4cba-8f3f-22e83308c696
July 06, 2018
3
September 12, 2016
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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
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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