i9 Diagnostic Ultrasound System

GUDID 06945121407304

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 ID	06945121407304
NIH Device Record Key	993b6eb8-939d-49a4-b79d-8e60c47ef46f
Commercial Distribution Status	In Commercial Distribution
Brand Name	i9 Diagnostic Ultrasound System
Version Model Number	i9
Company DUNS	544914187
Company Name	CHISON Medical Technologies Co., Ltd.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945121406574 [Primary]
GS1	06945121407090 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution
GS1	06945121407106 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution
GS1	06945121407113 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution
GS1	06945121407120 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution
GS1	06945121407137 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution
GS1	06945121407144 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution
GS1	06945121407151 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution
GS1	06945121407168 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution
GS1	06945121407175 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution
GS1	06945121407182 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution
GS1	06945121407199 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution
GS1	06945121407205 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution
GS1	06945121407212 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution
GS1	06945121407229 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution
GS1	06945121407236 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution
GS1	06945121407243 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution
GS1	06945121407250 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution
GS1	06945121407267 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution
GS1	06945121407274 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution
GS1	06945121407281 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution
GS1	06945121407298 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution
GS1	06945121407304 [Package] Contains: 06945121406574 Package: [1 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K140364

FDA Product Code

IYO	System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2018-07-06
Device Publish Date	2016-10-08

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