FDA.reportPublic FDA data

FlexFlow Venous Cannula

Primary DI
10803622147286
Brand
FlexFlow Venous Cannula
Company
LIVANOVA USA, INC.
Model
200-200
Published
2020-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052081000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052081000REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULAEstech, Inc.2005-12-16DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10803622147286PackageGS15In Commercial Distribution
00803622147289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080362214728610803622147286
00803622147289008036221472898036221472890803622147289

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass cannula, venousA sterile, semi-rigid or rigid tube intended to be used during open heart surgery where it is surgically inserted, typically into the right atrium and superior/inferior vena cava, to serve as a channel for the transport of blood to a cardiopulmonary bypass system (heart-lung machine) tubing circuit where the blood is pumped and oxygenated. It is typically a moulded plastic tube with stainless steel wire reinforcement, to prevent kinking/collapse, and having multiple perforations at the distal end and possibly a non-reinforced clamping site at the proximal end. It is typically inserted using a compatible trocar. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080914995
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00803622163623Perfusion PackPerfusion Pack2026-07-10
00803622163906Perfusion PackPerfusion Pack2026-07-10
00803622163975Perfusion PackPerfusion Pack2026-07-10
00803622163999Perfusion PackPerfusion Pack2026-07-10
00803622164002Perfusion PackPerfusion Pack2026-07-10
00803622119484Cardioplegia PackCardioplegia Pack2015-04-22
00803622163524Perfusion PackPerfusion Pack2026-07-08
00803622120138Perfusion PackPerfusion Pack2015-04-22
00803622163937Perfusion PackPerfusion Pack2026-06-26
00803622164019Perfusion PackPerfusion Pack2026-06-26
05425025750870VNS Therapy™ Programmer, Model 3100 v2.1.031002026-06-24
00803622163715Perfusion PackPerfusion Pack2026-06-08
00803622163722Perfusion PackPerfusion Pack2026-06-08
00803622163586Perfusion PackPerfusion Pack2026-05-27
00803622163593Perfusion PackPerfusion Pack2026-05-27
00803622163616Perfusion PackPerfusion Pack2026-05-27
00803622163654Perfusion PackPerfusion Pack2026-05-27
00803622163678Perfusion PackPerfusion Pack2026-05-27
00803622163685Perfusion PackPerfusion Pack2026-05-27
00803622163746Perfusion PackPerfusion Pack2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00824846004028NAMEDTRONIC, INC.DWF2026-07-16
00824846003151NAMEDTRONIC, INC.DWF2026-07-09
00840479401416enableCV EZ Glide Aortic CannulaENABLECV INC.DWF2026-07-09
00840479401430enableCV EZ Glide Aortic CannulaENABLECV INC.DWF2026-07-09
00824846003472NAMEDTRONIC, INC.DWF2026-07-04
00824846003687NAMEDTRONIC, INC.DWF2026-07-04
00824846003700NAMEDTRONIC, INC.DWF2026-07-04
00824846001669NAMEDTRONIC, INC.DWF2026-06-28
00824846001843NAMEDTRONIC, INC.DWF2026-06-28
00824846001850NAMEDTRONIC, INC.DWF2026-06-28
00840479402222enableCV Percutaneous Insertion Kit-ArterialENABLECV INC.DWF2026-06-26
00824846001614NAMEDTRONIC, INC.DWF2026-06-25
08033178019378Protek DuoSORIN GROUP ITALIA SRLDWF2026-06-25
08033178019385Protek DuoSORIN GROUP ITALIA SRLDWF2026-06-25
00199150083855NAMEDTRONIC, INC.DWF2026-06-08
00199150083992NAMEDTRONIC, INC.DWF2026-06-08
00199150084180NAMEDTRONIC, INC.DWF2026-06-08
00824846000020NAMEDTRONIC, INC.DWF2026-06-08
00824846000983NAMEDTRONIC, INC.DWF2026-06-08
00824846001027NAMEDTRONIC, INC.DWF2026-06-08
00824846001041NAMEDTRONIC, INC.DWF2026-06-08
00824846001065NAMEDTRONIC, INC.DWF2026-06-08
00199150083077NAMEDTRONIC, INC.DWF2026-05-30
00199150083121NAMEDTRONIC, INC.DWF2026-05-30
00199150083381NAMEDTRONIC, INC.DWF2026-05-30
00199150083442NAMEDTRONIC, INC.DWF2026-05-30
00199150083534NAMEDTRONIC, INC.DWF2026-05-30
00199150083718NAMEDTRONIC, INC.DWF2026-05-30
00199150083763NAMEDTRONIC, INC.DWF2026-05-30
00199150083794NAMEDTRONIC, INC.DWF2026-05-30