CBit Series Digital Color Doppler Ultrasound System

GUDID 06945121413039

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
Primary Device ID06945121413039
NIH Device Record Keye606fa7f-9e12-460e-adb0-46e98bec73ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameCBit Series Digital Color Doppler Ultrasound System
Version Model NumberCBit 9
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
GS106945121413015 [Primary]
GS106945121413039 [Package]
Contains: 06945121413015
Package: [1 Units]
In Commercial Distribution
GS106945121413053 [Package]
Contains: 06945121413015
Package: [1 Units]
In Commercial Distribution
GS106945121413404 [Package]
Contains: 06945121413015
Package: [1 Units]
In Commercial Distribution
GS106945121413411 [Package]
Contains: 06945121413015
Package: [1 Units]
In Commercial Distribution
GS106945121414623 [Package]
Contains: 06945121413015
Package: [1 Units]
In Commercial Distribution
GS106945121414630 [Package]
Contains: 06945121413015
Package: [1 Units]
In Commercial Distribution
GS106945121414647 [Package]
Contains: 06945121413015
Package: [1 Units]
In Commercial Distribution
GS106945121414654 [Package]
Contains: 06945121413015
Package: [1 Units]
In Commercial Distribution
GS106945121414661 [Package]
Contains: 06945121413015
Package: [1 Units]
In Commercial Distribution
GS106945121414678 [Package]
Contains: 06945121413015
Package: [1 Units]
In Commercial Distribution
GS106945121414685 [Package]
Contains: 06945121413015
Package: [1 Units]
In Commercial Distribution
GS106945121414692 [Package]
Contains: 06945121413015
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 Date2021-03-04
Device Publish Date2021-02-24

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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