Affinity Fusion™

GUDID 00643169785762

OXY/CVR COMBO CB841 FUSION CORTIVA US

MEDTRONIC, INC.

Extracorporeal membrane oxygenator
Primary Device ID00643169785762
NIH Device Record Keyf802788f-5fe0-4ef3-809f-bc71e8bfbf7b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAffinity Fusion™
Version Model NumberCB841
Company DUNS006261481
Company NameMEDTRONIC, 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 Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169785762 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTNRESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-22
Device Publish Date2017-01-16

On-Brand Devices [Affinity Fusion™]

00643169785762OXY/CVR COMBO CB841 FUSION CORTIVA US
00643169785731OXYGENATOR CB811 FUSION CORTIVA US
20643169178025RECIR LINE RCL841 FOR FUSION OXY/CVR
00763000225476FPA FUSION OXY CB811 CORTIVA 2L
00763000225469FPA FUSION CB841 CORTIVA US 2L
00763000834234OXY/CVR COMBO BB841 FUSION BALANCE 2L
00763000834210OXYGENATOR BB811 FUSION BALANCE 2L

Trademark Results [Affinity Fusion]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AFFINITY FUSION
AFFINITY FUSION
85173318 4332295 Live/Registered
Medtronic, Inc.
2010-11-10

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