ECO Series Diagnostic Ultrasound Systems

GUDID 06945121407915

CHISON Medical Technologies Co., Ltd.

Foetal Doppler system probe
Primary Device ID06945121407915
NIH Device Record Keyd2132ace-f318-4b47-b4a6-07e143c2a19d
Commercial Distribution StatusIn Commercial Distribution
Brand NameECO Series Diagnostic Ultrasound Systems
Version Model NumberECO 1
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
GS106945121407311 [Primary]
GS106945121407847 [Package]
Contains: 06945121407311
Package: [1 Units]
In Commercial Distribution
GS106945121407854 [Package]
Contains: 06945121407311
Package: [1 Units]
In Commercial Distribution
GS106945121407861 [Package]
Contains: 06945121407311
Package: [1 Units]
In Commercial Distribution
GS106945121407878 [Package]
Contains: 06945121407311
Package: [1 Units]
In Commercial Distribution
GS106945121407885 [Package]
Contains: 06945121407311
Package: [1 Units]
In Commercial Distribution
GS106945121407892 [Package]
Contains: 06945121407311
Package: [1 Units]
In Commercial Distribution
GS106945121407908 [Package]
Contains: 06945121407311
Package: [1 Units]
In Commercial Distribution
GS106945121407915 [Package]
Contains: 06945121407311
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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