CBit Series Digital Color Doppler Ultrasound System

GUDID 06945121412933

CHISON Medical Technologies Co., Ltd.

General-purpose ultrasound imaging system
Primary Device ID06945121412933
NIH Device Record Key364168d6-16a4-45ce-b886-4f41182f460f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCBit Series Digital Color Doppler Ultrasound System
Version Model NumberCBit 6
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
GS106945121412896 [Primary]
GS106945121412902 [Package]
Contains: 06945121412896
Package: [1 Units]
In Commercial Distribution
GS106945121412919 [Package]
Contains: 06945121412896
Package: [1 Units]
In Commercial Distribution
GS106945121412926 [Package]
Contains: 06945121412896
Package: [1 Units]
In Commercial Distribution
GS106945121412933 [Package]
Contains: 06945121412896
Package: [1 Units]
In Commercial Distribution
GS106945121413152 [Package]
Contains: 06945121412896
Package: [1 Units]
In Commercial Distribution
GS106945121413169 [Package]
Contains: 06945121412896
Package: [1 Units]
In Commercial Distribution
GS106945121413572 [Package]
Contains: 06945121412896
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 Date2019-09-24
Device Publish Date2019-09-16

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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