FDA.reportPublic FDA data

Surge Cardiovascular

Primary DI
00817278010132
Brand
Surge Cardiovascular
Company
Alliant Enterprises, LLC
Model
213-0251
Catalog number
213-0251
Device description
Vein Graft Cannula, Blunt Tip, free-flow
Published
2016-09-23
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

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817278010139PackageGS125Not in Commercial Distribution
00817278010132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081727801013910817278010139
00817278010132008172780101328172780101320817278010132

GMDN Terms#

Term, Definition table
TermDefinition
Vascular irrigation cannula, cardiac vessel graftA sterile, single-lumen, tubular device designed to be used during cardiac surgery to flush an autologous graft, typically a section of explanted saphenous vein, to test its integrity and the closure of lateral vessels, as well as to remove debris and clots after resection. It is typically made of plastic material (e.g., polypropylene) and typically designed with a connector at the proximal end (e.g., is attached to a syringe with a Luer connector) and a ribbed flange at the distal end for a secure connection to the vessel. It may also be used to perfuse the heart through the graft after having done the anastomosis on the coronary artery. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
121170653
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817278010149Surge Cardiovascular213-026213-0262016-09-23
00817278010897Surge CardiovascularPER-1407S-C02PER-1407S-C022016-09-23
00817278010903Surge CardiovascularPER-1401S-C05PER-1401S-C052016-09-23
00817278011269Surge CardiovascularSSD-100ASSD-100A2016-09-23
00817278011696Surge Cardiovascular5756NS5756NS2018-03-27
00817278011979Surge Cardiovascular213-028213-0282016-09-23
00817278011986Surge Cardiovascular213-0252213-02522016-09-23
00817278012396Terumo Cardiovascular SystemsT402210T4022102018-04-25
00817278011276Surge CardiovascularSUC-4300SUC-43002016-09-23
00817278011757Surge CardiovascularSUC-0840SUC-08402016-09-23
10817278010009Surge CardiovascularSUT-010SUT-0102016-09-23
10817278010016Surge CardiovascularSUT-013SUT-0132016-09-23
10817278010023Surge Cardiovascular213-013213-0132016-09-23
10817278010887Surge CardiovascularSUT-014SUT-0142016-09-23
10817278011952MicroSurgeSUT-M110SUT-M1102016-09-23
10817278011969MicroSurgeSUT-M114SUT-M1142016-09-23
10817278010115Surge Cardiovascular213-002213-0022016-09-23
10817278010122Surge Cardiovascular213-004213-0042016-09-23
10817278010955Surge Cardiovascular213-003213-0032016-09-23
10817278010962Surge Cardiovascular213-003NS213-003NS2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00199150083800NAMEDTRONIC, INC.DWF2026-05-30
00199150083817NAMEDTRONIC, INC.DWF2026-05-30
00199150083893NAMEDTRONIC, INC.DWF2026-05-30
00199150083985NAMEDTRONIC, INC.DWF2026-05-30
18051160302878Quantum SuperPAC Tubing Set - SP05E-BBSPECTRUM MEDICAL SRLDWF2026-05-27
00199150078455NAMEDTRONIC, INC.DWF2026-04-26
08033178017190Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017206Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017213Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017220Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017237Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017244Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017251Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017268Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017275Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017312Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178018074Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178018098Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178018104Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019026Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019033Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019040Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11