Waveline ECO with CO2

GUDID 00815871022774

Avante

Single-patient intensive/general healthcare physiologic monitoring system Single-patient intensive/general healthcare physiologic monitoring system Single-patient intensive/general healthcare physiologic monitoring system General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor
Primary Device ID00815871022774
NIH Device Record Key888eec19-a616-46bc-b32f-52b3e7194d14
Commercial Distribution StatusIn Commercial Distribution
Brand NameWaveline ECO with CO2
Version Model Number6G001CO2
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 Datefalse
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
Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com
Phone502-244-4444
Emaildevicehelp@dremed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100815871022774 [Primary]

FDA Product Code

MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-06
Device Publish Date2018-05-15

Devices Manufactured by Avante

00815871020091 - Disposable Monopolar Handswitching Pencil2020-03-02
00815871020190 - Compact FM2020-03-02
00815871020206 - Compact FM2020-03-02
00815871020213 - Compact FM2020-03-02
00815871020220 - Compact FM2020-03-02
00815871020237 - Compact Plus2020-03-02
00815871020244 - Compact Plus2020-03-02
00815871020251 - Compact Plus2020-03-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.