Clarius Ultrasound Scanner 99-02-00025; 99-02-00014

GUDID 07540205000182

Clarius Mobile Health Corp

Noninvasive device battery charger
Primary Device ID07540205000182
NIH Device Record Keyfeb04da5-957e-4ffd-8f68-5712beb9b48d
Commercial Distribution StatusIn Commercial Distribution
Brand NameClarius Ultrasound Scanner
Version Model NumberDock Station
Catalog Number99-02-00025; 99-02-00014
Company DUNS202522751
Company NameClarius Mobile Health Corp
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107540205000182 [Direct Marking]
GS107540205000342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-06
Device Publish Date2017-09-28

On-Brand Devices [Clarius Ultrasound Scanner]

07540205000847Multi-port lithium ion battery charger
07540205000861Mobile cart with multi-port battery charger
07540205000724Clarius Fan
07540205000120Clarius brand L7 Premium scanner
07540205000090Clarius brand C3 Premium scanner
07540205000564Clarius brand L7
07540205000540Clarius brand C3-45 scanner
07540205000533Clarius brand Charger
07540205000403App - Android
07540205000397App - iOS
07540205000182Dock Station
07540205000335Battery - ARTHREX
07540205000083C3-60 Premium
07540205000175ARTHREX Charger
07540205000168Battery
07540205001158Clarius fan
07540205000946High-density transducer type – endocavity array (Clarius Scanner EC7 HD)
07540205000915Clarius charger
07540205000908Clarius Battery HD
07540205000977High-density veterinary transducer type – phased array (Clarius Scanner PA HD)
07540205000960High-density transducer type – high-frequency linear array (Clarius Scanner L15 HD)
07540205000953High-density transducer type – linear array (Clarius Scanner L7 HD)
07540205000939High-density transducer type – micro-curvilinear array (Clarius Scanner C7 HD)
07540205000991High-density transducer type – curvilinear array (Clarius Scanner C3 HD)
07540205000984High-density transducer type - high-frequency linear array (Clarius Scanner L20 HD)
07540205001042The Clarius 2-in-1 Charging Station HD is a charging station that combines a dock for charging H
07540205001370Accessory - Fan for Clarius Ultrasound Scanner
07540205001363Accessory - Charger for Clarius Ultrasound Scanner
07540205001325Portable Ultrasound Scanner
07540205001318Portable Ultrasound Scanner
07540205001301Portable Ultrasound Scanner
07540205001295Portable Ultrasound Scanner
07540205001288Portable Ultrasound Scanner.
07540205001271Portable Ultrasound Scanner
07540205001189Portable Ultrasound Scanner
07540205001356Portable Ultrasound Scanner

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