CBit Series Digital Color Doppler Ultrasound Syste

GUDID 06945121412407

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
Primary Device ID06945121412407
NIH Device Record Keya21736d8-352c-4dd6-9942-883a12ba17a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameCBit Series Digital Color Doppler Ultrasound Syste
Version Model NumberCBit 8
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
GS106945121412308 [Primary]
GS106945121412384 [Package]
Contains: 06945121412308
Package: [1 Units]
In Commercial Distribution
GS106945121412391 [Package]
Contains: 06945121412308
Package: [1 Units]
In Commercial Distribution
GS106945121412407 [Package]
Contains: 06945121412308
Package: [1 Units]
In Commercial Distribution
GS106945121412414 [Package]
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Package: [1 Units]
In Commercial Distribution
GS106945121412421 [Package]
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Package: [1 Units]
In Commercial Distribution
GS106945121412438 [Package]
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Package: [1 Units]
In Commercial Distribution
GS106945121412445 [Package]
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Package: [1 Units]
In Commercial Distribution
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Package: [1 Units]
In Commercial Distribution
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Package: [1 Units]
In Commercial Distribution
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Package: [1 Units]
In Commercial Distribution
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Package: [1 Units]
In Commercial Distribution
GS106945121412490 [Package]
Contains: 06945121412308
Package: [1 Units]
In Commercial Distribution
GS106945121412506 [Package]
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Package: [1 Units]
In Commercial Distribution
GS106945121412513 [Package]
Contains: 06945121412308
Package: [1 Units]
In Commercial Distribution
GS106945121412520 [Package]
Contains: 06945121412308
Package: [1 Units]
In Commercial Distribution
GS106945121412537 [Package]
Contains: 06945121412308
Package: [1 Units]
In Commercial Distribution
GS106945121412544 [Package]
Contains: 06945121412308
Package: [1 Units]
In Commercial Distribution
GS106945121412551 [Package]
Contains: 06945121412308
Package: [1 Units]
In Commercial Distribution
GS106945121412568 [Package]
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Package: [1 Units]
In Commercial Distribution
GS106945121412575 [Package]
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Package: [1 Units]
In Commercial Distribution
GS106945121412582 [Package]
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Package: [1 Units]
In Commercial Distribution
GS106945121412599 [Package]
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Package: [1 Units]
In Commercial Distribution
GS106945121412605 [Package]
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Package: [1 Units]
In Commercial Distribution
GS106945121412612 [Package]
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Package: [1 Units]
In Commercial Distribution
GS106945121412629 [Package]
Contains: 06945121412308
Package: [1 Units]
In Commercial Distribution
GS106945121412636 [Package]
Contains: 06945121412308
Package: [1 Units]
In Commercial Distribution
GS106945121412643 [Package]
Contains: 06945121412308
Package: [1 Units]
In Commercial Distribution
GS106945121412650 [Package]
Contains: 06945121412308
Package: [1 Units]
In Commercial Distribution
GS106945121412667 [Package]
Contains: 06945121412308
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-27
Device Publish Date2018-08-27

Devices Manufactured by CHISON Medical Technologies Co., Ltd.

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06945121414524 - SonoAir Series Digital Color Doppler Ultrasound System2023-08-15
06945121414531 - Convex probe2023-08-15
06945121414548 - Linear probe2023-08-15
06945121414555 - Phased array probe2023-08-15
06945121414562 - Convex probe2023-08-15
06945121414579 - Micro convex probe2023-08-15
06945121414609 - SonoAir Series Digital Color Doppler Ultrasound System2023-08-15
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