i8 Diagnostic Ultrasound System

GUDID 06945121407083

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 ID06945121407083
NIH Device Record Keyb74988f4-288a-473d-a2fd-d986c1bf99db
Commercial Distribution StatusIn Commercial Distribution
Brand Namei8 Diagnostic Ultrasound System
Version Model Numberi8
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
GS106945121406567 [Primary]
GS106945121406871 [Package]
Contains: 06945121406567
Package: [1 Units]
In Commercial Distribution
GS106945121406888 [Package]
Contains: 06945121406567
Package: [1 Units]
In Commercial Distribution
GS106945121406895 [Package]
Contains: 06945121406567
Package: [1 Units]
In Commercial Distribution
GS106945121406901 [Package]
Contains: 06945121406567
Package: [1 Units]
In Commercial Distribution
GS106945121406918 [Package]
Contains: 06945121406567
Package: [1 Units]
In Commercial Distribution
GS106945121406925 [Package]
Contains: 06945121406567
Package: [1 Units]
In Commercial Distribution
GS106945121406932 [Package]
Contains: 06945121406567
Package: [1 Units]
In Commercial Distribution
GS106945121406949 [Package]
Contains: 06945121406567
Package: [1 Units]
In Commercial Distribution
GS106945121406956 [Package]
Contains: 06945121406567
Package: [1 Units]
In Commercial Distribution
GS106945121406963 [Package]
Contains: 06945121406567
Package: [1 Units]
In Commercial Distribution
GS106945121406970 [Package]
Contains: 06945121406567
Package: [1 Units]
In Commercial Distribution
GS106945121406987 [Package]
Contains: 06945121406567
Package: [1 Units]
In Commercial Distribution
GS106945121406994 [Package]
Contains: 06945121406567
Package: [1 Units]
In Commercial Distribution
GS106945121407007 [Package]
Contains: 06945121406567
Package: [1 Units]
In Commercial Distribution
GS106945121407014 [Package]
Contains: 06945121406567
Package: [1 Units]
In Commercial Distribution
GS106945121407021 [Package]
Contains: 06945121406567
Package: [1 Units]
In Commercial Distribution
GS106945121407038 [Package]
Contains: 06945121406567
Package: [1 Units]
In Commercial Distribution
GS106945121407045 [Package]
Contains: 06945121406567
Package: [1 Units]
In Commercial Distribution
GS106945121407052 [Package]
Contains: 06945121406567
Package: [1 Units]
In Commercial Distribution
GS106945121407069 [Package]
Contains: 06945121406567
Package: [1 Units]
In Commercial Distribution
GS106945121407076 [Package]
Contains: 06945121406567
Package: [1 Units]
In Commercial Distribution
GS106945121407083 [Package]
Contains: 06945121406567
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 Number4
Public Version Date2018-07-06
Device Publish Date2016-10-08

Devices Manufactured by CHISON Medical Technologies Co., Ltd.

06945121414524 - SonoAir Series Digital Color Doppler Ultrasound System2023-08-15
06945121414531 - Convex probe2023-08-15
06945121414548 - Linear probe2023-08-15
06945121414555 - Phased array probe2023-08-15
06945121414562 - Convex probe2023-08-15
06945121414579 - Micro convex probe2023-08-15
06945121414609 - SonoAir Series Digital Color Doppler Ultrasound System2023-08-15
06945121414777 - SonoAir Series Digital Color Doppler Ultrasound System2023-08-15

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