i7 Diagnostic Ultrasound System

GUDID 06945121406864

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	06945121406864
NIH Device Record Key	db4327eb-89dc-4c98-98e2-53f37f4190e3
Commercial Distribution Status	In Commercial Distribution
Brand Name	i7 Diagnostic Ultrasound System
Version Model Number	i7
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	06945121406550 [Primary]
GS1	06945121406659 [Package] Contains: 06945121406550 Package: [1 Units] In Commercial Distribution
GS1	06945121406666 [Package] Contains: 06945121406550 Package: [1 Units] In Commercial Distribution
GS1	06945121406673 [Package] Contains: 06945121406550 Package: [1 Units] In Commercial Distribution
GS1	06945121406680 [Package] Contains: 06945121406550 Package: [1 Units] In Commercial Distribution
GS1	06945121406697 [Package] Contains: 06945121406550 Package: [1 Units] In Commercial Distribution
GS1	06945121406703 [Package] Contains: 06945121406550 Package: [1 Units] In Commercial Distribution
GS1	06945121406710 [Package] Contains: 06945121406550 Package: [1 Units] In Commercial Distribution
GS1	06945121406727 [Package] Contains: 06945121406550 Package: [1 Units] In Commercial Distribution
GS1	06945121406734 [Package] Contains: 06945121406550 Package: [1 Units] In Commercial Distribution
GS1	06945121406741 [Package] Contains: 06945121406550 Package: [1 Units] In Commercial Distribution
GS1	06945121406758 [Package] Contains: 06945121406550 Package: [1 Units] In Commercial Distribution
GS1	06945121406765 [Package] Contains: 06945121406550 Package: [1 Units] In Commercial Distribution
GS1	06945121406772 [Package] Contains: 06945121406550 Package: [1 Units] In Commercial Distribution
GS1	06945121406789 [Package] Contains: 06945121406550 Package: [1 Units] In Commercial Distribution
GS1	06945121406796 [Package] Contains: 06945121406550 Package: [1 Units] In Commercial Distribution
GS1	06945121406802 [Package] Contains: 06945121406550 Package: [1 Units] In Commercial Distribution
GS1	06945121406819 [Package] Contains: 06945121406550 Package: [1 Units] In Commercial Distribution
GS1	06945121406826 [Package] Contains: 06945121406550 Package: [1 Units] In Commercial Distribution
GS1	06945121406833 [Package] Contains: 06945121406550 Package: [1 Units] In Commercial Distribution
GS1	06945121406840 [Package] Contains: 06945121406550 Package: [1 Units] In Commercial Distribution
GS1	06945121406857 [Package] Contains: 06945121406550 Package: [1 Units] In Commercial Distribution
GS1	06945121406864 [Package] Contains: 06945121406550 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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06945121414562 - Convex probe	2023-08-15
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