CBit Series Digital Color Doppler Ultrasound System

GUDID 06945121413435

CHISON Medical Technologies Co., Ltd.

General-purpose ultrasound imaging system
Primary Device ID06945121413435
NIH Device Record Keyc7a7dfda-d20b-4f89-9804-7bd3a3f82e37
Commercial Distribution StatusIn Commercial Distribution
Brand NameCBit Series Digital Color Doppler Ultrasound System
Version Model NumberCBit 10
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
GS106945121413428 [Primary]
GS106945121413435 [Package]
Contains: 06945121413428
Package: [1 Units]
In Commercial Distribution
GS106945121413442 [Package]
Contains: 06945121413428
Package: [1 Units]
In Commercial Distribution
GS106945121413817 [Package]
Contains: 06945121413428
Package: [1 Units]
In Commercial Distribution
GS106945121413824 [Package]
Contains: 06945121413428
Package: [1 Units]
In Commercial Distribution
GS106945121413831 [Package]
Contains: 06945121413428
Package: [1 Units]
In Commercial Distribution
GS106945121413848 [Package]
Contains: 06945121413428
Package: [1 Units]
In Commercial Distribution
GS106945121413855 [Package]
Contains: 06945121413428
Package: [1 Units]
In Commercial Distribution
GS106945121413862 [Package]
Contains: 06945121413428
Package: [1 Units]
In Commercial Distribution
GS106945121413879 [Package]
Contains: 06945121413428
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 Date2021-11-03
Device Publish Date2021-10-26

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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