FDA.reportPublic FDA data

ProtekDuo

Primary DI
00814112020319
Brand
ProtekDuo
Company
CARDIACASSIST, INC.
Model
5140-5131
Device description
31 Fr x 51 cm Veno-Venous Dual Lumen Cannula with Introducer
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K160257000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160257000PROTEK Duo 31 Fr. Veno-Venous Cannula SetCardiacassist, Inc.2016-03-04DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814112020319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814112020319008141120203198141120203190814112020319

GMDN Terms#

Term, Definition table
TermDefinition
Mobile extracorporeal gas exchange system catheter kitA collection of sterile devices that is a component of a mobile extracorporeal gas exchange system and which includes a dedicated dual-lumen venous catheter. The catheter is designed to conduct blood from the patient and return it to the venous system (veno-venous) after extracorporeal circulation and gas exchange; it is intended for use with femoral or jugular veins and is designed for low-resistance to flow while also resisting kinks. In addition to the catheter, the kit typically includes a syringe, needles, guidewires, a scalpel, and dilators. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18003737421gjohnson@tandemlife.com
+14129637770gjohnson@tandemlife.com

Regulatory Flags#

DUNS number
948683941
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814112020166PROTEK Duo5140-46292015-10-10
00814112020067TandemHeart5140-62212015-10-10
00814112020098TandemHeart5140-62172015-10-10
00814112020104TandemHeart5130-17175130-17172015-10-10
00814112020111TandemHeart5130-17155130-17152015-10-10
00814112020449ProtekSolo5140-60245140-60242017-01-27
00814112020456ProtekDuo5100-14262017-05-22
00814112020623LifeSPARC5900-00012020-05-27
00814112020630LifeSPARC5900-00022020-05-27
00814112020692TandemLife LifeSPARC5840-24172020-06-01
00814112020906LifeSPARC5900-00125900-00122022-05-10
00814112020609LifeSPARC5800-10002020-05-29
00814112020685TandemLife LifeSPARC5840-00002020-05-29
00814112020753TandemLung LifeSPARC5830-29162020-05-29
00814112020760TandemLung LifeSPARC5830-31182020-05-29
00814112020777TandemLung LifeSPARC5830-36312020-05-29
00814112020814LifeSPARC5800-10012020-05-29
00814112020562LifeSPARC5900-00002019-12-18
00814112020579LifeSPARC5900-00032019-12-18
00814112020593LifeSPARC5800-00002019-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00824846004028NAMEDTRONIC, INC.DWF2026-07-16
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