QBit Series Diagnostic Ultrasound System

GUDID 06945121403221

CHISON Medical Technologies Co., Ltd.

Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe 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 ID06945121403221
NIH Device Record Keyf44c5754-5843-43d7-9b39-acc77e8c1edf
Commercial Distribution StatusIn Commercial Distribution
Brand NameQBit Series Diagnostic Ultrasound System
Version Model NumberQBit 5
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
GS106945121403221 [Primary]
GS106945121404396 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404402 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404419 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404426 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404433 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404440 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404457 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404464 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404471 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404488 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404495 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404501 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404518 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404525 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404532 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404549 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404556 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404563 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404570 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404587 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404594 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404600 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404617 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404624 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404631 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404648 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404655 [Package]
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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [QBit Series Diagnostic Ultrasound System]

06945121403269QBit 9
06945121403245QBit 7
06945121403221QBit 5
06945121414715QBit 3
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