ECO Series Diagnostic Ultrasound Systems

GUDID 06945121407991

CHISON Medical Technologies Co., Ltd.

Foetal Doppler system probe
Primary Device ID06945121407991
NIH Device Record Key7dfe2eb6-947e-4405-b9e8-8367ed53f240
Commercial Distribution StatusIn Commercial Distribution
Brand NameECO Series Diagnostic Ultrasound Systems
Version Model NumberECO 2
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
GS106945121407328 [Primary]
GS106945121407922 [Package]
Contains: 06945121407328
Package: [1 Units]
In Commercial Distribution
GS106945121407939 [Package]
Contains: 06945121407328
Package: [1 Units]
In Commercial Distribution
GS106945121407946 [Package]
Contains: 06945121407328
Package: [1 Units]
In Commercial Distribution
GS106945121407953 [Package]
Contains: 06945121407328
Package: [1 Units]
In Commercial Distribution
GS106945121407960 [Package]
Contains: 06945121407328
Package: [1 Units]
In Commercial Distribution
GS106945121407977 [Package]
Contains: 06945121407328
Package: [1 Units]
In Commercial Distribution
GS106945121407984 [Package]
Contains: 06945121407328
Package: [1 Units]
In Commercial Distribution
GS106945121407991 [Package]
Contains: 06945121407328
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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