AFFINITY®NT

GUDID 20613994375647

OXYGENATOR 95213 AFFINITY 2PK 541R

MEDTRONIC, INC.

Extracorporeal membrane oxygenator
Primary Device ID20613994375647
NIH Device Record Keyccfc9b40-9cd3-494c-a635-cde3756b60fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameAFFINITY®NT
Version Model Number95213
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count2
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 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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994375643 [Unit of Use]
GS120613994375647 [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 Number4
Public Version Date2020-01-22
Device Publish Date2016-09-09

Devices Manufactured by MEDTRONIC, INC.

00763000180010 - Sprint Quattro Secure S™2024-11-12 LEAD 693552 SPRINT US RCMCRD
00763000180027 - Sprint Quattro Secure S™2024-11-12 LEAD 693575 SPRINT US RCMCRD
00763000180034 - Sprint Quattro Secure S™2024-11-12 LEAD 6935100 SPRINT US RCMCRD
00763000180041 - Sprint Quattro Secure S MRI™ SureScan™2024-11-12 LEAD 693558 SPRINT MRI US RCMCRD
00763000180058 - Sprint Quattro Secure S MRI™ SureScan™2024-11-12 LEAD 693565 SPRINT MRI US RCMCRD
00763000180119 - Sprint Quattro Secure S MRI™ SureScan™2024-11-12 LEAD 6935M55 MRI US DF4 RCMCRD
00763000180126 - Sprint Quattro Secure S MRI™ SureScan™2024-11-12 LEAD 6935M62 MRI US DF4 RCMCRD
00763000180133 - Sprint Quattro Secure S™2024-11-12 LEAD 6935M49 US DF4 RCMCRD

Trademark Results [AFFINITY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AFFINITY
AFFINITY
98533674 not registered Live/Pending
Affinity Petcare, S.A.
2024-05-03
AFFINITY
AFFINITY
98391212 not registered Live/Pending
FloraCraft Corporation
2024-02-05
AFFINITY
AFFINITY
98171032 not registered Live/Pending
Affinity Family Care, LLC
2023-09-08
AFFINITY
AFFINITY
98007525 not registered Live/Pending
Affinity Automotive Products, Inc.
2023-05-22
AFFINITY
AFFINITY
97875538 not registered Live/Pending
Milk Care Co. Inc.
2023-04-06
AFFINITY
AFFINITY
97728207 not registered Live/Pending
INDUSTRIAS MEDICAS SAMPEDRO S.A.S.
2022-12-22
AFFINITY
AFFINITY
97652101 not registered Live/Pending
Colin Wayne Bell
2022-10-28
AFFINITY
AFFINITY
97481758 not registered Live/Pending
Waters Technologies Corporation
2022-06-29
AFFINITY
AFFINITY
97352098 not registered Live/Pending
AFFINITY EQUITY PARTNERS LIMITED
2022-04-07
AFFINITY
AFFINITY
97226979 not registered Live/Pending
Melinicoff Associates, LLC
2022-01-19
AFFINITY
AFFINITY
97125444 not registered Live/Pending
REGENXBIO Inc.
2021-11-15
AFFINITY
AFFINITY
97079527 not registered Live/Pending
Locus LP
2021-10-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.