EBit Series Diagnostic Ultrasound System

GUDID 06945121410861

CHISON Medical Technologies Co., Ltd.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system
Primary Device ID06945121410861
NIH Device Record Keyf7f2c995-c34b-4291-ac98-266ed436628b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEBit Series Diagnostic Ultrasound System
Version Model NumberEBit 50
Company DUNS544914187
Company NameCHISON Medical Technologies Co., Ltd.
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 Datetrue
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
GS106945121410861 [Primary]
GS106945121410878 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410885 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410892 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410908 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410915 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410922 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410939 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410946 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410953 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410960 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410977 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410984 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410991 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411004 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411011 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411028 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411035 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411042 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411059 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411066 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411073 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411080 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411097 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411103 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411110 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411127 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411134 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411141 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411158 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411165 [Package]
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2017-04-20

On-Brand Devices [EBit Series Diagnostic Ultrasound System]

06945121410861EBit 50
06945121409704EBit 60
06945121412889EBit 30
06945121414494EBit 20
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