QBit Series Diagnostic Ultrasound System

GUDID 06945121403245

CHISON Medical Technologies Co., Ltd.

Foetal Doppler system probe
Primary Device ID06945121403245
NIH Device Record Key242815a4-4386-4aea-90bd-898c94c00b17
Commercial Distribution StatusIn Commercial Distribution
Brand NameQBit Series Diagnostic Ultrasound System
Version Model NumberQBit 7
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
GS106945121403245 [Primary]
GS106945121404938 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404945 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404952 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404969 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404976 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404983 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121404990 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405003 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405010 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405027 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405034 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405041 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405058 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405065 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405072 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405089 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405096 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405102 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405119 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405126 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405133 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405140 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405157 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405164 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405171 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405188 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121405195 [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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