Integra SL

GUDID 00815871020077

Avante

Anaesthesia unit, mobile
Primary Device ID00815871020077
NIH Device Record Key9efcb83b-f1d6-4b8c-be07-a36a4cf9d5f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntegra SL
Version Model Number00104
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100815871020077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BSZGas-Machine, Anesthesia

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-06-19
Device Publish Date2015-12-23

Devices Manufactured by Avante

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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

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