XBit Series Digital Color Doppler Ultrasound System

GUDID 06945121413794

CHISON Medical Technologies Co., Ltd.

General-purpose ultrasound imaging system
Primary Device ID06945121413794
NIH Device Record Keyfe5d8b91-497d-46ca-a21f-9ab27bcfef23
Commercial Distribution StatusIn Commercial Distribution
Brand NameXBit Series Digital Color Doppler Ultrasound System
Version Model NumberXBit 80
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
GS106945121413787 [Primary]
GS106945121413794 [Package]
Contains: 06945121413787
Package: [1 Units]
In Commercial Distribution
GS106945121413800 [Package]
Contains: 06945121413787
Package: [1 Units]
In Commercial Distribution
GS106945121413886 [Package]
Contains: 06945121413787
Package: [1 Units]
In Commercial Distribution
GS106945121413893 [Package]
Contains: 06945121413787
Package: [1 Units]
In Commercial Distribution
GS106945121413909 [Package]
Contains: 06945121413787
Package: [1 Units]
In Commercial Distribution
GS106945121413916 [Package]
Contains: 06945121413787
Package: [1 Units]
In Commercial Distribution
GS106945121413923 [Package]
Contains: 06945121413787
Package: [1 Units]
In Commercial Distribution
GS106945121413930 [Package]
Contains: 06945121413787
Package: [1 Units]
In Commercial Distribution
GS106945121413947 [Package]
Contains: 06945121413787
Package: [1 Units]
In Commercial Distribution
GS106945121413954 [Package]
Contains: 06945121413787
Package: [1 Units]
In Commercial Distribution
GS106945121413961 [Package]
Contains: 06945121413787
Package: [1 Units]
In Commercial Distribution
GS106945121413978 [Package]
Contains: 06945121413787
Package: [1 Units]
In Commercial Distribution
GS106945121413985 [Package]
Contains: 06945121413787
Package: [1 Units]
In Commercial Distribution
GS106945121413992 [Package]
Contains: 06945121413787
Package: [1 Units]
In Commercial Distribution
GS106945121414012 [Package]
Contains: 06945121413787
Package: [1 Units]
In Commercial Distribution
GS106945121414036 [Package]
Contains: 06945121413787
Package: [1 Units]
In Commercial Distribution
GS106945121414210 [Package]
Contains: 06945121413787
Package: [1 Units]
In Commercial Distribution
GS106945121414760 [Package]
Contains: 06945121413787
Package: [1 Units]
In Commercial Distribution
GS106945121415392 [Package]
Contains: 06945121413787
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-18
Device Publish Date2022-07-10

Devices Manufactured by CHISON Medical Technologies Co., Ltd.

06945121415385 - Linear probe2024-09-23
06945121414883 - Micro convex probe2024-08-26
06945121414814 - SonoMax Series Digital Color Doppler Ultrasound System2024-08-23
06945121415200 - SonoMax Series Digital Color Doppler Ultrasound System2024-08-23
06945121415194 - Digital Color Doppler Palm Ultrasound System2024-06-11
06945121414524 - SonoAir Series Digital Color Doppler Ultrasound System2023-08-15
06945121414531 - Convex probe2023-08-15
06945121414548 - Linear probe2023-08-15

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