AccessGUDID - DEVICE: VuMAX HD Ophthalmic Ultrasound System (00896100002217)

GUDID

Device Identifier (DI) Information

Brand Name: VuMAX HD Ophthalmic Ultrasound System
Version or Model: VuMAX HD A/B/UBM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BUA.575
Company Name: SONOMED, INC.

Primary DI Number: 00896100002217
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 107037079 *Terms of Use

Device Description: The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active, bio-microscope (UBM) device for imaging ocular features for diagnostic purposes. It combines both A-scan and B-scan modes ultilizing a 35 MHz and/or 50 MHz transducer with a sector scanning probe and operates on a computer-based platform. The A-scan measures axial length (AXL), anterior chamber depth, lens thickness and vitreous length. B-scan settings include orbit, virtreous body, retina surface, and deep retina/choroid. UBM capabilities include sulcus-to-sulcus, angle detail, high resolution, and motion picture settings. The system includes the multi-frequency ultrasound system base unit, 22" LCD, water-path probe with 35 MHz transducer, 12 MHz B-probe, 10 mHz A-probe, keyboard and mouse, USB foot switch, immersion cups and user manual.

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?
11389	Ophthalmic ultrasound imaging system	An assembly of mains electricity (AC-powered) devices designed for ophthalmic imaging procedures. It includes software that supports a variety of static and real-time eye and orbital imaging applications including physical measurement and oncology related treatment. It will generate ultrasound pulses, direct them to a target area, detect the resulting ultrasound echoes, and process the resulting information producing and displaying static or dynamic two- or three-dimensional (3-D) images. This GMDN code includes ultrasound imaging systems with, e.g., A-mode, B-mode, Doppler, colour Doppler (CD), M-mode, and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYO	System, Imaging, Pulsed Echo, Ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060626	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: aa6437fc-3867-4f2b-baa9-fdcf42bf6ebe
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 10, 2016