DEVICE: Delica (06970481940109)
Device Identifier (DI) Information
Delica
EMS-9D EXP
In Commercial Distribution
Shenzhen Delica Medical Equipment Co., Ltd.
EMS-9D EXP
In Commercial Distribution
Shenzhen Delica Medical Equipment Co., Ltd.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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36970 | Noninvasive vascular ultrasound system probe |
A hand-operated component of a noninvasive vascular ultrasound system intended to be placed on the surface of a patient's body to measure the flow of blood in the underlying vasculature using ultrasonic/Doppler/transit time technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow graphically, typically with sound. The device is available in various frequency capacities (e.g., 4, 5, or 8 MHz). It may also be used to detect the foetal heartbeat. This is a reusable device.
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Active | false |
61422 | Noninvasive vascular ultrasound system, line-powered |
A mains electricity (AC-powered) device assembly consisting of a desktop unit, a graphical display unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. Clinical applications include venous/arterial flow screening (e.g., assessment of air embolism, atherosclerosis, varicose veins, venous thrombosis), ankle pressure index, and/or blood flow wave form recording.
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Obsolete | false |
34978 | Blood pressure cuff, reusable |
A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.
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Active | false |
61237 | Noninvasive haemodynamic monitoring system |
An assembly of mains electricity (AC-powered) devices intended to be used for the noninvasive continuous measurement of arterial blood pressure, cardiac output, and other haemodynamic variables by automated radial arterial tonometry. It consists of a bracelet-like detection device worn on the wrist and an attached monitor with user interface. It is typically used in the operating arena or the intensive care unit (ICU).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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DXQ | Blood Pressure Cuff |
DXN | System, Measurement, Blood-Pressure, Non-Invasive |
ITX | Transducer, Ultrasonic, Diagnostic |
OQQ | Diagnostic Ultrasonic Transducer, Robotic |
IYN | System, Imaging, Pulsed Doppler, Ultrasonic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K190228 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6ea28fb4-0239-4bd2-a84c-6385ef8e8674
November 03, 2023
3
June 20, 2019
November 03, 2023
3
June 20, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
No Customer Contact currently defined