FDA.reportPublic FDA data

AngioVac

Primary DI
H965251990
Brand
AngioVac
Company
Angiodynamics, Inc.
Model
25199
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
H965251990PrimaryHIBCC0
15051684019866SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505168401986615051684019866

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
+1(800)772-6446customerservice@angiodynamics.com

Regulatory Flags#

DUNS number
079252781
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H787065068010Micro Access065068012016-09-20
H787065068020Micro Access065068022016-09-20
H787065068030Micro Access065068032016-09-20
H787065068040Micro Access065068042016-09-20
H787065068050Micro Access065068052016-09-20
H787065072010Micro Access065072012016-09-20
H787065072020Micro Access065072022016-09-20
H787065072030Micro Access065072032016-09-20
H787065072040Micro Access065072042016-09-20
H787065072100Morpheus065072102016-09-20
H787065072110Morpheus065072112016-09-20
H787065072120Morpheus065072122016-09-20
H787065072130Morpheus065072132016-09-20
H787065076010Embosafe065076012016-09-20
H787065076020Embosafe065076022016-09-20
H787065076030Embosafe065076032016-09-20
H787065084020Morpheus065084022016-09-20
H787065084030Morpheus065084032016-09-20
H787065084040Morpheus065084042016-09-20
H787065086010Micro Access065086012016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00803622164842Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164927Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164934Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164941Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164958Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164989Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164996Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622165047Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622165054Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164774Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164781Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164798Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164866Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164873Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164880Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164897Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164903Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164736Perfusion PackLIVANOVA USA, INC.DWE2026-09-29
00803622164743Perfusion PackLIVANOVA USA, INC.DWE2026-09-29
00803622164651Perfusion PackLIVANOVA USA, INC.DWE2026-09-28
00803622164675Perfusion PackLIVANOVA USA, INC.DWE2026-09-28
00803622164682Perfusion PackLIVANOVA USA, INC.DWE2026-09-28
00803622164705Perfusion PackLIVANOVA USA, INC.DWE2026-09-28
00803622164712Perfusion PackLIVANOVA USA, INC.DWE2026-09-28
00803622164729Perfusion PackLIVANOVA USA, INC.DWE2026-09-28
00803622164767Perfusion PackLIVANOVA USA, INC.DWE2026-09-28
00803622164477Perfusion PackLIVANOVA USA, INC.DWE2026-09-22