vivid iq

GUDID 00840682143882

GE Medical Systems (China) Co.,Ltd.

Cardiovascular ultrasound imaging system
Primary Device ID00840682143882
NIH Device Record Key06ce813b-077a-4a8c-8ba6-f72cadc694bc
Commercial Distribution StatusIn Commercial Distribution
Brand Namevivid iq
Version Model Numbervivid iq R1R2 to R3 UPG
Company DUNS654658731
Company NameGE Medical Systems (China) 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

Operating and Storage Conditions

Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682143882 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-02
Device Publish Date2019-03-25

Devices Manufactured by GE Medical Systems (China) Co.,Ltd.

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00195278300034 - Versana2023-06-23 Supra R2 basic console for Balance VS
00195278300096 - Versana2023-06-23 Supra R2 basic console for Balance VA
00195278503404 - Versana2023-06-21 Versana Essential R2 VS
00195278503411 - Versana2023-06-21 Versana Essiential R2 VA
00195278421388 - Vivid2022-09-07 Vivid iq R6 basic console
00195278422279 - Vivid2022-09-07 T9 v206 console

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