AccessGUDID - DEVICE: Dolphin/XF Robot Accessory (07290016880229)

GUDID

Device Identifier (DI) Information

Brand Name: Dolphin/XF Robot Accessory
Version or Model: Dolphin/XF Robot Accessory
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: VIASONIX LTD

Primary DI Number: 07290016880229
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 533070236 *Terms of Use

Device Description: The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assists the user in the acquisition of cerebral blood flow velocity

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:	No
Combination Product:	No
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?
40761	General-purpose ultrasound imaging system	A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K202742	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: d9e0e5ac-7e52-4246-a2e6-ff04c2d57cab
Public Version Date: April 08, 2021
Public Version Number: 1
DI Record Publish Date: March 31, 2021