FDA.reportPublic FDA data

Surge Cardiovascular

Primary DI
00817278010248
Brand
Surge Cardiovascular
Company
Med Michigan Holdings, LLC
Model
ANT-2012S
Catalog number
ANT-2012S
Device description
Antegrade Cardioplegia Cannula 12Ga(9Fr) w/VentLine & Insertion Needle 14ga
Published
2016-09-23
Public version status
Update
Distribution status
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
10817278010245PackageGS120In Commercial Distribution
00817278010248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081727801024510817278010245
00817278010248008172780102488172780102480817278010248

GMDN Terms#

Term, Definition table
TermDefinition
Cardioplegia cannulaA sterile, single lumen, tubular device designed to deliver cardioplegic solution to the aortic root to stop the beating of the heart and maintain it dormant; it may also be used to vent the aorta and the left heart during a cardiopulmonary bypass procedure. It is typically made of plastic [e.g., polypropylene, polyvinyl chloride (PVC)] with a soft insertion tip and a suture flange for its anchoring; it may have one or more tubes (a second for aspiration, if needed), and typically Luer connector(s) for connection to the infusion syringe and aspiration line(s). It may include a manual tubing clamp and insertion is typically achieved with a removable stylet. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
097462979
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
00817278010118Surge Cardiovascular213-002213-0022016-09-23
00817278010125Surge Cardiovascular213-004213-0042016-09-23
00817278010958Surge Cardiovascular213-003213-0032016-09-23
00817278010965Surge Cardiovascular213-003NS213-003NS2016-09-23
00817278012341Surge CardiovascularFEM-V1020FEM-V10202017-10-30
00817278012358Surge CardiovascularFEM-V1022FEM-V10222017-10-30
00817278012365Surge CardiovascularFEM-V1024FEM-V10242017-10-30
00817278012372Surge CardiovascularFEM-V1026FEM-V10262017-10-30
00817278012389Surge CardiovascularFEM-V1028FEM-V10282017-10-30
00817278012020Patriot ProPP-BLM-22150PP-BLM-221502024-06-04
00817278010002Surge CardiovascularSUT-010SUT-0102016-09-23
00817278010019Surge CardiovascularSUT-013SUT-0132016-09-23
00817278010026Surge Cardiovascular213-013213-0132016-09-23
00817278010156Surge Cardiovascular215-015215-0152016-09-23
00817278010163Surge Cardiovascular215-030215-0302016-09-23
00817278010170Surge Cardiovascular215-044215-0442016-09-23
00817278010224Surge CardiovascularACIPACIP2016-09-23
00817278010231Surge CardiovascularANT-1014SANT-1014S2016-09-23
00817278010255Surge CardiovascularANT-2014SANT-2014S2016-09-23
00817278010262Surge CardiovascularCAR-1613SCAR-1613S2016-09-23

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