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
00803622164804Perfusion PackPerfusion Pack2026-10-19
00803622164811Perfusion PackPerfusion Pack2026-10-19
00803622164842Perfusion PackPerfusion Pack2026-10-19
00803622164910Perfusion PackPerfusion Pack2026-10-19
00803622164927Perfusion PackPerfusion Pack2026-10-19
00803622164934Perfusion PackPerfusion Pack2026-10-19
00803622164941Perfusion PackPerfusion Pack2026-10-19
00803622164958Perfusion PackPerfusion Pack2026-10-19
00803622164989Perfusion PackPerfusion Pack2026-10-19
00803622164996Perfusion PackPerfusion Pack2026-10-19
00803622165047Perfusion PackPerfusion Pack2026-10-19
00803622165054Perfusion PackPerfusion Pack2026-10-19
00803622103001Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103018Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103025Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103032Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103049Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103056Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103063Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103070Cardioplegia cannulaAR-xxxxx2015-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00803622104091Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104107Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104114Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104121Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104138Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104145Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104152Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104169Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622105692Venous cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104176Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104183Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104190Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104206Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104213Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104220Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104237Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104244Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104251Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104268Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104275Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104282Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104299Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104305Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104312Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104329Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104336Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104343Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104350Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104367Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104374Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17