AccessGUDID - DEVICE: ScanNav Anatomy Peripheral Nerve Block (05060878810021)

GUDID

Device Identifier (DI) Information

Brand Name: ScanNav Anatomy Peripheral Nerve Block
Version or Model: V1.1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: INTELLIGENT ULTRASOUND LIMITED

Primary DI Number: 05060878810021
Issuing Agency: GS1
Commercial Distribution End Date: October 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 218445981 *Terms of Use

Device Description: ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD) which assists qualified healthcare professionals to identify anatomy in live ultrasound images. The Anatomy PNB receives scan images in real-time from a compatible general-purpose ultrasound machine. It then processes the images using deep learning artificial intelligence algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The original view from the ultrasound machine is not affected and is always available both on the ultrasound machine and the Anatomy PNB.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
40873	Ultrasound imaging system application software	An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QRG	Ultrasound Guided Nerve Block Assist

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN220024	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: 401131ee-f384-4c32-b4d2-14c4ad9a8d84
Public Version Date: December 02, 2024
Public Version Number: 3
DI Record Publish Date: March 01, 2023