ECO Series Diagnostic Ultrasound Systems

GUDID 06945121408158

CHISON Medical Technologies Co., Ltd.

Foetal Doppler system probe
Primary Device ID06945121408158
NIH Device Record Key615367bf-1feb-4417-8b50-5801c3047a98
Commercial Distribution StatusIn Commercial Distribution
Brand NameECO Series Diagnostic Ultrasound Systems
Version Model NumberECO 5
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
GS106945121407342 [Primary]
GS106945121408080 [Package]
Contains: 06945121407342
Package: [1 Units]
In Commercial Distribution
GS106945121408097 [Package]
Contains: 06945121407342
Package: [1 Units]
In Commercial Distribution
GS106945121408103 [Package]
Contains: 06945121407342
Package: [1 Units]
In Commercial Distribution
GS106945121408110 [Package]
Contains: 06945121407342
Package: [1 Units]
In Commercial Distribution
GS106945121408127 [Package]
Contains: 06945121407342
Package: [1 Units]
In Commercial Distribution
GS106945121408134 [Package]
Contains: 06945121407342
Package: [1 Units]
In Commercial Distribution
GS106945121408141 [Package]
Contains: 06945121407342
Package: [1 Units]
In Commercial Distribution
GS106945121408158 [Package]
Contains: 06945121407342
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [ECO Series Diagnostic Ultrasound Systems]

06945121408158ECO 5
06945121408073ECO 3
06945121407991ECO 2
06945121407915ECO 1

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