CBit Series Digital Color Doppler Ultrasound System

GUDID 06945121413480

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 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 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 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 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 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 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 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 ID06945121413480
NIH Device Record Key8e019f11-f3dd-4560-95b7-90144d59bdb9
Commercial Distribution StatusIn Commercial Distribution
Brand NameCBit Series Digital Color Doppler Ultrasound System
Version Model NumberXBit 90
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
GS106945121413459 [Primary]
GS106945121413480 [Package]
Contains: 06945121413459
Package: [1 Units]
In Commercial Distribution
GS106945121413619 [Package]
Contains: 06945121413459
Package: [1 Units]
In Commercial Distribution
GS106945121413633 [Package]
Contains: 06945121413459
Package: [1 Units]
In Commercial Distribution
GS106945121413732 [Package]
Contains: 06945121413459
Package: [1 Units]
In Commercial Distribution
GS106945121413749 [Package]
Contains: 06945121413459
Package: [1 Units]
In Commercial Distribution
GS106945121413756 [Package]
Contains: 06945121413459
Package: [1 Units]
In Commercial Distribution
GS106945121414043 [Package]
Contains: 06945121413459
Package: [1 Units]
In Commercial Distribution
GS106945121414050 [Package]
Contains: 06945121413459
Package: [1 Units]
In Commercial Distribution
GS106945121414067 [Package]
Contains: 06945121413459
Package: [1 Units]
In Commercial Distribution
GS106945121414074 [Package]
Contains: 06945121413459
Package: [1 Units]
In Commercial Distribution
GS106945121414081 [Package]
Contains: 06945121413459
Package: [1 Units]
In Commercial Distribution
GS106945121414098 [Package]
Contains: 06945121413459
Package: [1 Units]
In Commercial Distribution
GS106945121414104 [Package]
Contains: 06945121413459
Package: [1 Units]
In Commercial Distribution
GS106945121414111 [Package]
Contains: 06945121413459
Package: [1 Units]
In Commercial Distribution
GS106945121414128 [Package]
Contains: 06945121413459
Package: [1 Units]
In Commercial Distribution
GS106945121414142 [Package]
Contains: 06945121413459
Package: [1 Units]
In Commercial Distribution
GS106945121414203 [Package]
Contains: 06945121413459
Package: [1 Units]
In Commercial Distribution
GS106945121414708 [Package]
Contains: 06945121413459
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 Date2021-11-10
Device Publish Date2021-11-02

On-Brand Devices [CBit Series Digital Color Doppler Ultrasound System]

06945121412933CBit 6
06945121413039CBit 9
06945121413145CBit 4
06945121413220CBit 5
06945121413398XBit 70
06945121413435CBit 10
06945121413480XBit 90
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