E-ST

GUDID 00815871020398

Avante

General-purpose ultrasound imaging system
Primary Device ID00815871020398
NIH Device Record Key0327e5a5-31af-4536-bdb6-abd36b2a1f81
Commercial Distribution StatusIn Commercial Distribution
Brand NameE-ST
Version Model Number60133
Company DUNS178440426
Company NameAvante
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100815871020398 [Primary]

FDA Product Code

HEPMonitor, Blood-Flow, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-19
Device Publish Date2016-09-23

On-Brand Devices [E-ST]

0081587102042860132PRO2
0081587102041160132PRO
0081587102040460133-8
0081587102039860133
00815871020381601324
00815871020374601323
0081587102036760132

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