Home GUDID 07540205000106 Viera Portable Breast Ultrasound
Primary DI 07540205000106
Brand Viera Portable Breast Ultrasound
Company Clarius Mobile Health Corp
Model Viera Portable Breast Ultrasound Linear Scanner
Catalog number 81-02-00011; 50-02-00006
Published 2018-03-27
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name ITX Transducer, Ultrasonic, Diagnostic IYO System, Imaging, Pulsed Echo, Ultrasonic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ITX Transducer, Ultrasonic, Diagnostic Radiology 2 IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07540205000106 Direct Marking GS1 0 07540205000045 Primary GS1 0 07540205000205 Primary GS1 0 07540205000557 Primary GS1 0 07540205000601 Primary GS1 0 07540205000670 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07540205000106 07540205000106 7540205000106 07540205000045 07540205000045 7540205000045 07540205000205 07540205000205 7540205000205 07540205000557 07540205000557 7540205000557 07540205000601 07540205000601 7540205000601 07540205000670 07540205000670 7540205000670
GMDN Terms# Term, Definition table Term Definition Hand-held ultrasound imaging system, body-surface A battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition be intended to be used with a sterile cover for intraoperative imaging. It consists of a flat- or concave-lensed ultrasound transducer and includes an integrated image processing system; it may include an integrated display or be intended to wirelessly transmit images to an off-the-shelf device (e.g., smartphone, tablet) with dedicated software installed. It is not designed to be inserted into the vagina or rectum.
Regulatory Flags# DUNS number 202522751 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07540205001356 Clarius Ultrasound Scanner Clarius Scanner PAL HD3 99-13-00029, 99-02-00085 2024-02-01 07540205000397 Clarius Ultrasound Scanner App - iOS 12-01-00003 2017-04-25 07540205000403 Clarius Ultrasound Scanner App - Android 12-01-00004 2017-04-25 07540205000168 Clarius Ultrasound Scanner Battery 99-02-00001 2017-04-25 07540205000335 Clarius Ultrasound Scanner Battery - ARTHREX 80-02-00001; AR-3500-01B 2017-04-25 07540205001196 Clarius Ultrasound Scanner Clarius Scanner L7 HD3 99-13-00020, 99-02-00077 2022-09-29 07540205001202 Clarius Ultrasound Scanner Clarius Scanner C7 HD3 99-13-00019, 99-02-00075 2022-09-29 07540205001219 Clarius Ultrasound Scanner Clarius Scanner EC7 HD3 99-13-00024, 99-02-00076 2022-09-29 07540205001226 Clarius Ultrasound Scanner Clarius Scanner L15 HD3 99-13-00021, 99-02-00078 2022-09-29 07540205001233 Clarius Ultrasound Scanner Clarius Scanner PA HD3 99-13-00023, 99-02-00080 2022-09-29 07540205001240 Clarius Ultrasound Scanner Clarius Scanner L20 HD3 99-13-00022, 99-02-00079 2022-09-29 07540205001349 Clarius Ultrasound Scanner Clarius Charger HD3 99-13-00030, 99-03-00023 2022-09-29 07540205001189 Clarius Ultrasound Scanner Clarius Scanner C3 HD3 99-13-00018, 99-02-00074 2022-09-29 07540205001271 Clarius Ultrasound Scanner Clarius Scanner L7 HD3 99-13-00020, 99-02-00077 2022-09-29 07540205001288 Clarius Ultrasound Scanner Clarius Scanner C7 HD3 99-13-00019, 99-02-00075 2022-09-29 07540205001295 Clarius Ultrasound Scanner Clarius Scanner EC7 HD3 99-13-00024, 99-02-00076 2022-09-29 07540205001301 Clarius Ultrasound Scanner Clarius Scanner L15 HD3 99-13-00021, 99-02-00078 2022-09-29 07540205001318 Clarius Ultrasound Scanner Clarius Scanner PA HD3 99-13-00023, 99-02-00080 2022-09-29 07540205001325 Clarius Ultrasound Scanner Clarius Scanner L20 HD3 99-13-00022, 99-02-00079 2022-09-29 07540205001363 Clarius Ultrasound Scanner Clarius Charger HD3 99-13-00030, 99-03-00023 2022-09-29
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