FDA.reportPublic FDA data

MC3 Crescent RA Dual Lumen Catheter 13FR

Primary DI
10850007732209
Brand
MC3 Crescent RA Dual Lumen Catheter 13FR
Company
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
Model
70413
Catalog number
70413
Device description
The Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in adult and pediatric patients with acute respiratory failure requiring VenoVenous Extracorporeal Membrane Oxygenation where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
Published
2021-09-01
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850007732209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085000773220910850007732209

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
806687406
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850007732247VitalFlow Console58100581002024-09-19
10850007732421Nautilus VF Oxygenator Cable581302025-07-24
10850007732513MC3 Crescent RA Dual Lumen Catheter 13FR70413704132025-04-16
10850007732520MC3 Crescent RA Dual Lumen Catheter 15FR70415704152025-04-16
10850007732537MC3 Crescent RA Dual Lumen Catheter 19FR70419704192025-04-16
10850007732346VitalFlow Centrifugal Pump 58111581112024-09-20
10850007732254VitalFlow Motor Drive58102581022024-09-19
10850007732261VitalFlow Emergency Handcrank58103581032024-09-19
10850007732278VitalFlow Flow and Bubble Sensor, 2m58150581502024-09-19
10850007732285VitalFlow Power Cord NEMA-5-15, 3m58131581312024-09-19
10850007732292VitalFlow Power Cord CEE 7/7, 2.5m58132581322024-09-19
10850007732308VitalFlow Power Cord 12 V DC, 3m58141581412024-09-19
10850007732315Nautilus VF ECMO Oxygentaor58110581102024-09-19
10850007732322Nautilus VF Oxygenator Cable58130481502024-09-19
10850007732339VitalFlow Set58112581122024-09-19
10850007732353VitalFlow Caddy58120581202024-09-19
10854916006406MC3494849482018-01-10
10854916006420MC3494949492018-01-10
10854916006444MC3495049502018-01-10
10854916006482MC3576157612018-01-10

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
08033178019453PROTEK DUO+SORIN GROUP ITALIA SRLPZS2025-01-14
08033178019460PROTEK DUO+SORIN GROUP ITALIA SRLPZS2025-01-14
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