SOLENT OMNI 109681

GUDID 00616258003924

SOLENT OMNI CATHETER, FG PKG

Bayer Healthcare LLC

Thrombectomy suction catheter
Primary Device ID00616258003924
NIH Device Record Key9ba778ee-fba8-48f4-a536-e2c31f31a5b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOLENT OMNI
Version Model Number109681-001
Catalog Number109681
Company DUNS079415074
Company NameBayer Healthcare LLC
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone763-780-4555
Emailmichael.burnside@bayer.com
Phone763-780-4555
Emailmichael.burnside@bayer.com
Phone763-780-4555
Emailmichael.burnside@bayer.com
Phone763-780-4555
Emailmichael.burnside@bayer.com
Phone763-780-4555
Emailmichael.burnside@bayer.com
Phone763-780-4555
Emailmichael.burnside@bayer.com
Phone763-780-4555
Emailmichael.burnside@bayer.com
Phone763-780-4555
Emailmichael.burnside@bayer.com
Phone763-780-4555
Emailmichael.burnside@bayer.com
Phone763-780-4555
Emailmichael.burnside@bayer.com
Phone763-780-4555
Emailmichael.burnside@bayer.com
Phone763-780-4555
Emailmichael.burnside@bayer.com
Phone763-780-4555
Emailmichael.burnside@bayer.com

Device Dimensions

Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100616258003924 [Primary]

FDA Product Code

KRACatheter, Continuous Flush

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2014-10-07

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