FDA.reportPublic FDA data

Surge Cardiovascular

Primary DI
00817278012655
Brand
Surge Cardiovascular
Company
Med Michigan Holdings, LLC
Model
SSD-100A
Catalog number
SSD-100A
Device description
Suction Safety Device, Non-Sterile
Published
2018-03-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00817278012662PackageGS1100In Commercial Distribution
00817278012655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817278012662008172780126628172780126620817278012662
00817278012655008172780126558172780126550817278012655

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system valve, unidirectional flow/pressure controlA sterile, mechanical regulator used in a cardiopulmonary bypass system, particularly systems employing centrifugal pumps during open-heart surgery. It typically provides unidirectional flow to prevent inadvertent backflow of blood and air into the heart, and/or controls the pressure within the system (e.g., maintains gentle suction to prevent line collapse during left ventricular venting, or controls the vacuum from suctioning of the heart or the surgical field). 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
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
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
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