AccessGUDID - DEVICE: NovaBot Automated Headset (00850681007184)

GUDID

Device Identifier (DI) Information

Brand Name: NovaBot Automated Headset
Version or Model: NA-RBT1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NA-RBT1
Company Name: Novasignal Corp.

Primary DI Number: 00850681007184
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078766464 *Terms of Use

Device Description: NovaBot Automated Headset accessory for the Lucid TCD. When connected to the Lucid TCD, the combined device is referred to as the NovaGuide. The NovaBot is a cart mounted, robotic transcranial Doppler (TCD) probe positioning accessory for the previously cleared Lucid TCD (K160442) which assists the user in the acquisition of cerebral blood flow velocity (CBFV) and the occurrence of transient emboli within the blood stream, via the patient's temporal acoustic windows.

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?
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

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 [?]
K180455	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: e31f564e-9cf5-4cb0-9344-1768ba99fd18
Public Version Date: August 19, 2022
Public Version Number: 2
DI Record Publish Date: August 31, 2020