FDA.reportPublic FDA data

Surge Cardiovascular

Primary DI
00817278010484
Brand
Surge Cardiovascular
Company
Med Michigan Holdings, LLC
Model
RSN-M014S-L
Catalog number
RSN-M014S-L
Device description
"Retrograde Cardioplegia Cannula, Self-Inflating smooth, medium balloon, W/o stylet, 12.5"" legnth, 15Fr"
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
10817278010481PackageGS15In Commercial Distribution
00817278010484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081727801048110817278010481
00817278010484008172780104848172780104840817278010484

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
00817278010248Surge CardiovascularANT-2012SANT-2012S2016-09-23
00817278010255Surge CardiovascularANT-2014SANT-2014S2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18051160302878Quantum SuperPAC Tubing Set - SP05E-BBSPECTRUM MEDICAL SRLDWF2026-05-27
08033178019620Aortic Root cannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178019637Aortic Root cannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178019644Vessel CannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178019651Vessel CannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178019668Vessel CannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178019675Vessel CannulaSORIN GROUP ITALIA SRLDWF2026-03-06
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
08033178019057Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019064Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019071Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019088Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019095Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019101Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019118Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11