MC3 4948

GUDID 20854916006410

Soft Flow Extended 21 FR 7 MM NON VENTED

MICHIGAN CRITICAL CARE CONSULTANTS, INC.

Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial
Primary Device ID20854916006410
NIH Device Record Key746779a4-34f1-43c5-8320-047066fae902
Commercial Distribution StatusIn Commercial Distribution
Brand NameMC3
Version Model Number4948
Catalog Number4948
Company DUNS806687406
Company NameMICHIGAN CRITICAL CARE CONSULTANTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110854916006024 [Previous]
GS110854916006406 [Primary]
GS120854916006410 [Package]
Contains: 10854916006406
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-08-05
Device Publish Date2018-01-10

On-Brand Devices [MC3]

10854916006383Soft Flow Aortic 18FR 6MM ANGLED FLANGE VENTED
10854916006369Soft Flow Aortic 18FR 6MM ANGLED BULB VENTED
10854916006345Soft Flow Aortic 18FR 6MM ANGLED BULB NON VENTED
10854916006321Soft Flow Aortic 21FR 7MM ANGLED FLANGE VENTED
10854916006307Soft Flow Aortic 21FR 7MM ANGLED FLANGE NON VENTED
10854916006284Soft Flow Aortic 24FR 8MM ANGLED FLANGE VENTED
10854916006260Soft Flow Aortic 24FR 8MM ANGLED FLANGE NON VENTED
10854916006246Soft Flow Aortic 24 FR 8MM STRAIGHT BULB NON VENTED
10854916006222Soft Flow Aortic 21 FR 7MM STRAIGHT BULB NON VENTED
10854916006208Soft Flow Aortic 24 FR 8MM STRAIGHT BULB VENTED
10854916006185Soft Flow Aortic 21 FR 7MM STRAIGHT BULB VENTED
10854916006161Soft Flow Aortic 24FR 8MM ANGLED BULB NON VENTED
10854916006147Soft Flow Aortic 21FR 7MM ANGLED BULB NON VENTED
10854916006123Soft Flow Aortic 24FR 8MM ANGLED BULB VENTED
10854916006109Soft Flow Aortic 21FR 7MM ANGLED BULB VENTED
10854916006468Soft Flow Extended 24 FR 8MM VENTED
20854916006458Soft Flow Extended 24 FR 8MM NON VENTED
20854916006434Soft Flow Extended 21 FR 7MM VENTED
20854916006410Soft Flow Extended 21 FR 7 MM NON VENTED

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