FDA.reportPublic FDA data

MC3 Opus(tm) Vascular Access Kit

Primary DI
10854916006833
Brand
MC3 Opus(tm) Vascular Access Kit
Company
MICHIGAN CRITICAL CARE CONSULTANTS, INC.
Model
21030
Catalog number
21030
Device description
Vascular Access Kit
Published
2019-05-30
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
DREDilator, Vessel, For Percutaneous Catheterization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182914000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182914000MC3 Vascular Access Kit 21030Mc3 Incorporated2018-10-29DRE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20854916006847PackageGS15In Commercial Distribution
10854916006833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085491600684720854916006847
1085491600683310854916006833

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
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
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10850007732520MC3 Crescent RA Dual Lumen Catheter 15FR70415704152025-04-16
10850007732537MC3 Crescent RA Dual Lumen Catheter 19FR70419704192025-04-16
10850007732346VitalFlow Centrifugal Pump 58111581112024-09-20
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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
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