MyLab30 Gold Cardiovascular

GUDID 08056304450852

ESAOTE SPA

General-purpose ultrasound imaging system
Primary Device ID08056304450852
NIH Device Record Key698170f2-9e85-4572-a8bf-ff39b0dfcb92
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyLab30 Gold Cardiovascular
Version Model Number9807340001
Company DUNS437384304
Company NameESAOTE SPA
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108056304450852 [Primary]

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 Number5
Public Version Date2024-11-25
Device Publish Date2016-09-27

Devices Manufactured by ESAOTE SPA

08056304450852 - MyLab30 Gold Cardiovascular2024-11-25
08056304450852 - MyLab30 Gold Cardiovascular2024-11-25
08056304450869 - MyLab25 Gold2024-11-25
08056304451880 - PA121E2024-11-25
08056304452191 - TE122 2024-11-25 correct brand name is TEE122 with two E
08056304453419 - MyLabX82024-11-25
08056304454126 - MyLabX8 eXP2024-11-25
08056304455727 - G-scan Open2024-07-10
08056304455741 - O-scan Smart2024-07-10

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