FDA.reportPublic FDA data

Surge Cardiovascular

Primary DI
10817278010405
Brand
Surge Cardiovascular
Company
Alliant Enterprises, LLC
Model
PER-3007S
Catalog number
PER-3007S
Device description
Vessel Cannula, rigid, 3mm blunt tip
Published
2016-09-23
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817278010405PackageGS140In Commercial Distribution
00817278010408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081727801040510817278010405
00817278010408008172780104088172780104080817278010408

GMDN Terms#

Term, Definition table
TermDefinition
Cardioplegia solution administration adaptorA sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
121170653
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817278010009Surge CardiovascularSUT-010SUT-0102016-09-23
10817278010016Surge CardiovascularSUT-013SUT-0132016-09-23
10817278010023Surge Cardiovascular213-013213-0132016-09-23
00817278010033Surge Cardiovascular213-010213-0102016-09-23
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
10817278010269Surge CardiovascularCAR-1613SCAR-1613S2016-09-23
10817278010276Surge CardiovascularCAR-1615SCAR-1615S2016-09-23
20817278011355Surge CardiovascularCAR-1613CAR-16132016-09-23
10817278011990MicroSurgeBLM-22150BLM-221502016-09-23
10817278012003Terumo Cardiovascular SystemsT402210T4022102016-09-23
00817278012402Terumo Cardiovascular SystemsT402210T4022102018-04-25
10817278010139Surge Cardiovascular213-0251213-02512016-09-23
10817278010146Surge Cardiovascular213-026213-0262016-09-23
10817278011983Surge Cardiovascular213-0252213-02522016-09-23

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