FDA.reportPublic FDA data

AngioDynamics

Primary DI
H965251870
Brand
AngioDynamics
Company
NAVILYST MEDICAL, INC.
Model
25187
Device description
AngioVac Circuit Pack
Published
2016-09-20
Public version status
Update
Distribution status
Not 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
DWETUBING, PUMP, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWETubing, Pump, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142607000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142607000AngioVac CircuitAngiodynamics2014-12-11DWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H965251870PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system tubing setA collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags#

DUNS number
809699023
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H74904490200NAMIC04490202016-09-20
H965457480AngioDynamics457482016-09-20
H965457490AngioDynamics457492016-09-20
H965457500AngioDynamics457502016-09-20
H965457510AngioDynamics457512016-09-20
H965457520AngioDynamics457522016-09-20
H965457530AngioDynamics457532016-09-20
H965457540AngioDynamics457542016-09-20
H965457550AngioDynamics457552016-09-20
H965457560AngioDynamics457562016-09-20
H965457570AngioDynamics457572016-09-20
H965457580AngioDynamics457582016-09-20
H965457590AngioDynamics457592016-09-20
H965457600AngioDynamics457602016-09-20
H965457610AngioDynamics457612016-09-20
H965457620AngioDynamics457622016-09-20
H965457630AngioDynamics457632016-09-20
H965457640AngioDynamics457642016-09-20
H965457650AngioDynamics457652016-09-20
H965457660AngioDynamics457662016-09-20

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