Affinity NT™

GUDID 20763000232140

FPA 95250 AFFINITY TRILLIUM GLBL

MEDTRONIC, INC.

Extracorporeal membrane oxygenator
Primary Device ID20763000232140
NIH Device Record Key8974c2a5-8849-406c-9183-879703650531
Commercial Distribution StatusIn Commercial Distribution
Brand NameAffinity NT™
Version Model Number95250
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 Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000232146 [Primary]
GS120763000232140 [Package]
Contains: 00763000232146
Package: PK [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTZOXYGENATOR, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-09
Device Publish Date2020-03-01

On-Brand Devices [Affinity NT™]

00643169767843OXYGENATOR CB511 AFFINITY BIOACT 4PK
00643169767805OXYGENATOR CB541 AFFINITY PKGNG ASSY 2PK
20763000187846ICVR 541B BALANCE AFFINITY NT GLBL
20763000232126FPA 95217 AFFINITY TRILLIUM GLBL
20763000232089FPA 95215 AFFINITY TRILLIUM GLBL
20763000232140FPA 95250 AFFINITY TRILLIUM GLBL

Trademark Results [Affinity NT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AFFINITY NT
AFFINITY NT
75552115 2635702 Live/Registered
MEDTRONIC, INC.
1998-09-14

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