QBit Series Diagnostic Ultrasound System

GUDID 06945121403269

CHISON Medical Technologies Co., Ltd.

Foetal Doppler system probe
Primary Device ID06945121403269
NIH Device Record Key49520855-f10a-4f0b-a423-ed9f1dd9feb5
Commercial Distribution StatusIn Commercial Distribution
Brand NameQBit Series Diagnostic Ultrasound System
Version Model NumberQBit 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
GS106945121403269 [Primary]
GS106945121405478 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405485 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405492 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405508 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405515 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405522 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405539 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405546 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405553 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405560 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405577 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405584 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405591 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405607 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405614 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405621 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405638 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405645 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405652 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405669 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405676 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405683 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405690 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405706 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405713 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405720 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405737 [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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