CoAxia NeuroFlo™ Catheter 8700-000775-01

GUDID 00849111030007

A multi-lumen device with two balloons mounted near the distal tip.

Zoll Circulation, Inc.

Intravascular occluding balloon catheter, image-guided
Primary Device ID00849111030007
NIH Device Record Key535dfa2a-5d61-4072-9c87-3f553fc7b82a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoAxia NeuroFlo™ Catheter
Version Model Number1027
Catalog Number8700-000775-01
Company DUNS799455241
Company NameZoll Circulation, Inc.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100849111030007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUFCatheter, Neuro-Vasculature, Occluding Ballon

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-21
Device Publish Date2015-07-24

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