AccessGUDID - DEVICE: Delica (06970481940048)

GUDID

Device Identifier (DI) Information

Brand Name: Delica
Version or Model: EMS-9PB
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen Delica Medical Equipment Co., Ltd.

Primary DI Number: 06970481940048
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544412009 *Terms of Use

Device Description: Transcranial Doppler Ultrasound System with Robotic Probe Headband

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

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
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.

GMDN Preferred Term Name

GMDN Definition

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.

FDA Product Code

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Product Code	Product Code Name
OQQ	Diagnostic Ultrasonic Transducer, Robotic
IYN	System, Imaging, Pulsed Doppler, Ultrasonic
ITX	Transducer, Ultrasonic, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 33d0c778-7091-47e8-9bb6-7f584c8c96b6
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 19, 2016