FDA.reportPublic FDA data

PROTEK DUO+

Primary DI
08033178019453
Brand
PROTEK DUO+
Company
SORIN GROUP ITALIA SRL
Model
5100-2916
Published
2025-01-14
Public version status
New
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
PZSDual lumen ECMO cannula

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZSDual Lumen Ecmo CannulaCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232480000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232480000ProtekDuo Veno-Venous Cannula SetsCardiacassist, Inc.2023-10-06PZS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033178019453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033178019453080331780194538033178019453

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

Regulatory Flags#

DUNS number
442126587
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
08033178102933DHF02 HEMOCONCENTRATOR2015-07-15
08033178102940DHF06 HEMOCONCENTRATOR2015-07-15
08033178109062CSC 14CSC14 + PURGE LINE2015-07-10
08033178112253INSPIRE6M2015-05-13
08033178112277INSPIRE6F M2015-05-13
08033178112284INSPIRE8F M2015-05-13
08033178112291INSPIREHVR2015-05-13
08033178112307INSPIREHVR DUAL2015-05-13
08033178112352INSPIRE6 PH.I.S.I.O.2015-05-13
08033178112369INSPIRE8 PH.I.S.I.O.2015-05-13
08033178112376INSPIRE6F PH.I.S.I.O.2015-05-13
08033178112383INSPIRE8F PH.I.S.I.O.2015-05-13
08033178112390INSPIRE6 DUAL PH.I.S.I.O.2015-05-13
08033178112406INSPIRE8 DUAL PH.I.S.I.O.2015-05-13
08033178112413INSPIRE6F DUAL PH.I.S.I.O.2015-05-13
08033178112420INSPIRE8F DUAL PH.I.S.I.O.2015-05-13
08033178113014INSPIRESVR 12002017-03-29
08033178113182INSPIRE7 M2019-08-28
08033178113212INSPIRE72019-08-28
08033178113236INSPIRE7 DUAL2019-08-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850007732513MC3 Crescent RA Dual Lumen Catheter 13FRMICHIGAN CRITICAL CARE CONSULTANTS, INC.PZS2025-04-16
10850007732520MC3 Crescent RA Dual Lumen Catheter 15FRMICHIGAN CRITICAL CARE CONSULTANTS, INC.PZS2025-04-16
10850007732537MC3 Crescent RA Dual Lumen Catheter 19FRMICHIGAN CRITICAL CARE CONSULTANTS, INC.PZS2025-04-16
08033178019392PROTEK DUO+SORIN GROUP ITALIA SRLPZS2025-01-20
08033178019422PROTEK DUO+SORIN GROUP ITALIA SRLPZS2025-01-20
08033178019460PROTEK DUO+SORIN GROUP ITALIA SRLPZS2025-01-14
10850007732209MC3 Crescent RA Dual Lumen Catheter 13FRMICHIGAN CRITICAL CARE CONSULTANTS, INC.PZS2021-09-01
10850007732216MC3 Crescent RA Dual Lumen Catheter 15FRMICHIGAN CRITICAL CARE CONSULTANTS, INC.PZS2021-09-01
10850007732223MC3 Crescent RA Dual Lumen Catheter 19FRMICHIGAN CRITICAL CARE CONSULTANTS, INC.PZS2021-09-01
10850007732230MC3 Crescent RA Dual Lumen Catheter 24FRMICHIGAN CRITICAL CARE CONSULTANTS, INC.PZS2021-09-01
10854916006918MC3 Crescent(tm) Jugular Dual Lumen Catheter 24 FRMICHIGAN CRITICAL CARE CONSULTANTS, INC.PZS2019-06-03
10854916006925MC3 Crescent(tm) Jugular Dual Lumen CatheterMICHIGAN CRITICAL CARE CONSULTANTS, INC.PZS2019-06-03
10854916006932MC3 Crescent(tm) Jugular Dual Lumen Catheter MICHIGAN CRITICAL CARE CONSULTANTS, INC.PZS2019-06-03
10854916006949MC3 Crescent(tm) Jugular Dual Lumen CatheterMICHIGAN CRITICAL CARE CONSULTANTS, INC.PZS2019-06-03
10854916006956MC3 Crescent(tm) Jugular Dual Lumen CatheterMICHIGAN CRITICAL CARE CONSULTANTS, INC.PZS2019-06-03
10854916006789MC3 Crescent Jugular Dual Lumen CatheterMICHIGAN CRITICAL CARE CONSULTANTS, INC.PZS2018-07-30
10854916006796MC3 Crescent Jugular Dual Lumen CatheterMICHIGAN CRITICAL CARE CONSULTANTS, INC.PZS2018-07-30
10854916006802MC3 Crescent Jugular Dual Lumen CatheterMICHIGAN CRITICAL CARE CONSULTANTS, INC.PZS2018-07-30
10854916006819MC3 Crescent Jugular Dual Lumen CatheterMICHIGAN CRITICAL CARE CONSULTANTS, INC.PZS2018-07-30
10854916006826MC3 Crescent Jugular Dual Lumen CatheterMICHIGAN CRITICAL CARE CONSULTANTS, INC.PZS2018-07-30