FDA.reportPublic FDA data

CoAxia NeuroFlo™ Catheter

Primary DI
00849111030007
Brand
CoAxia NeuroFlo™ Catheter
Company
Zoll Circulation, Inc.
Model
1027
Catalog number
8700-000775-01
Device description
A multi-lumen device with two balloons mounted near the distal tip.
Published
2015-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUFCatheter, Neuro-Vasculature, Occluding Ballon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUFCatheter, Neurovasculature, Occluding BalloonNeurology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H030005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H030005000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849111030007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849111030007008491110300078491110300070849111030007

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat malformations (e.g., aneurysms), chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design, one for balloon inflation and another to pass it over a guidewire, or for the infusion of contrast medium, delivery of a smaller catheter, or embolic agents. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4085412140udisj@zoll.com

Regulatory Flags#

DUNS number
799455241
Device count
1
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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00849111050074Cool Line® Intravascular Heat Exchange Catheter Kit (Applause)N/A8700-0654-032015-03-31
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