Viera Portable Breast Ultrasound 81-02-00011; 50-02-00006

GUDID 07540205000106

Clarius Mobile Health Corp

Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface

Primary Device ID	07540205000106
NIH Device Record Key	973af822-8252-4fdb-8dbe-f148f7b75d73
Commercial Distribution Status	In Commercial Distribution
Brand Name	Viera Portable Breast Ultrasound
Version Model Number	Viera Portable Breast Ultrasound Linear Scanner
Catalog Number	81-02-00011; 50-02-00006
Company DUNS	202522751
Company Name	Clarius Mobile Health Corp
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540205000045 [Primary]
GS1	07540205000106 [Direct Marking]
GS1	07540205000205 [Primary]
GS1	07540205000557 [Primary]
GS1	07540205000601 [Primary]
GS1	07540205000670 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K172385

FDA Product Code

ITX	Transducer, Ultrasonic, Diagnostic
IYO	System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2018-12-21
Device Publish Date	2018-03-27

On-Brand Devices [Viera Portable Breast Ultrasound]

07540205000649	Viera Battery Charger
07540205000106	Viera Portable Breast Ultrasound Linear Scanner