FDA.reportPublic FDA data

Terumo Cardiovascular Systems

Primary DI
10817278010757
Brand
Terumo Cardiovascular Systems
Company
Alliant Enterprises, LLC
Model
824366
Catalog number
824366
Device description
Y Vent Adapter
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964200000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964200000CHASE MULTIPLE PERFUSION SETChase Medical, Inc.1997-04-16DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817278010757PackageGS120In Commercial Distribution
00817278010750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081727801075710817278010757
00817278010750008172780107508172780107500817278010750

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
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
00817278010132Surge Cardiovascular213-0251213-02512016-09-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00824846003151NAMEDTRONIC, INC.DWF2026-07-09
00840479401416enableCV EZ Glide Aortic CannulaENABLECV INC.DWF2026-07-09
00840479401430enableCV EZ Glide Aortic CannulaENABLECV INC.DWF2026-07-09
00824846003472NAMEDTRONIC, INC.DWF2026-07-04
00824846003687NAMEDTRONIC, INC.DWF2026-07-04
00824846003700NAMEDTRONIC, INC.DWF2026-07-04
00824846001669NAMEDTRONIC, INC.DWF2026-06-28
00824846001843NAMEDTRONIC, INC.DWF2026-06-28
00824846001850NAMEDTRONIC, INC.DWF2026-06-28
00840479402222enableCV Percutaneous Insertion Kit-ArterialENABLECV INC.DWF2026-06-26
00824846001614NAMEDTRONIC, INC.DWF2026-06-25
08033178019378Protek DuoSORIN GROUP ITALIA SRLDWF2026-06-25
08033178019385Protek DuoSORIN GROUP ITALIA SRLDWF2026-06-25
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