FDA.reportPublic FDA data

MC3 Crescent Jugular Dual Lumen Catheter

Primary DI
10854916006802
Brand
MC3 Crescent Jugular Dual Lumen Catheter
Company
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
Model
70128
Catalog number
70128
Device description
Dual Lumen ECMO Cannula
Published
2018-07-30
Public version status
Update
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
PSZDevices Detecting Influenza A, B, And C Virus Antigens
PZSDual Lumen Ecmo Cannula

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSZDevices Detecting Influenza A, B, And C Virus AntigensMicrobiology2
PZSDual Lumen Ecmo CannulaCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854916006802PreviousGS10
10854916006932PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085491600680210854916006802
1085491600693210854916006932

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge28French

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
00695684744250AimStep Flu A&B Test KitGERMAINE LABORATORIES, INCPSZ2026-05-11
06970640093097INNOVITAInnovita (Tangshan) Biological Technology Co., Ltd.PSZ2026-04-15
00742860100413Acucy Printer PaperSEKISUI DIAGNOSTICS, LLCPSZ2026-02-27
10742860100410Acucy Printer PaperSEKISUI DIAGNOSTICS, LLCPSZ2026-02-27
00742860100444Acucy Reader A/C AdapterSEKISUI DIAGNOSTICS, LLCPSZ2026-02-27
00742860100475Acucy System Universal DrawerSEKISUI DIAGNOSTICS, LLCPSZ2026-02-27
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
00895160002847Nano-Check Influenza+COVID-19 Dual TestNANO-DITECH CORPORATIONPSZ2024-08-08
20885380200844CARDINAL HEALTHCardinal Health 200, LLCPSZ2024-08-02
50885380200845CARDINAL HEALTHCardinal Health 200, LLCPSZ2024-08-02
00850056728706ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen TestLumos Diagnostics, Inc.PSZ2023-11-30
00848838027031Remel REMEL, INC.PSZ2021-11-12
30848838027032Remel REMEL, INC.PSZ2021-11-12
03848838027038Remel REMEL, INC.PSZ2021-11-12
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
10743816001553Status™ COVID-19/FluPRINCETON BIOMEDITECH CORPORATIONPSZ2021-02-15
00742860100390OSOM ULTRA PLUS FLU A&B Test SEKISUI DIAGNOSTICS, LLCPSZ2020-06-01
00742860100406OSOM ULTRA PLUS FLU A&B Control KitSEKISUI DIAGNOSTICS, LLCPSZ2020-06-01
10742860100397OSOM ULTRA PLUS FLU A&B Test SEKISUI DIAGNOSTICS, LLCPSZ2020-06-01
00742860100338Acucy SystemSEKISUI DIAGNOSTICS, LLCPSZ2019-09-24
00742860100345Acucy Calibration DeviceSEKISUI DIAGNOSTICS, LLCPSZ2019-09-24