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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Obsolete	false
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.	Active	false

FDA Product Code

[?]

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 [?]
K122710	000

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: November 03, 2023
Public Version Number: 4
DI Record Publish Date: September 19, 2016