TRILLIUM® AFFINITY NT®

GUDID 20613994375630

OXYGENATOR 95217 AFFINITY 541T 2PK

MEDTRONIC, INC.

Extracorporeal membrane oxygenator
Primary Device ID20613994375630
NIH Device Record Key8cafff7a-a3da-4361-ad3a-add16b7156d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRILLIUM® AFFINITY NT®
Version Model Number95217
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
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

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994375636 [Primary]
GS120613994375630 [Package]
Contains: 00613994375636
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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-22
Device Publish Date2015-09-21

On-Brand Devices [TRILLIUM® AFFINITY NT®]

20613994865971OXYGENATOR 95215 TRILLIUM AFF 511T 4PK
20613994375630OXYGENATOR 95217 AFFINITY 541T 2PK
20613994375623OXYGENATOR 95216 AFFINITY 541TR 2PK
20721902648896OXYGENATOR 95250 AFFINITY 2PK 511T 541TT

Trademark Results [TRILLIUM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRILLIUM
TRILLIUM
98804622 not registered Live/Pending
Ratio Therapeutics, Inc.
2024-10-16
TRILLIUM
TRILLIUM
98009169 not registered Live/Pending
Charles River Laboratories, Inc.
2023-05-23
TRILLIUM
TRILLIUM
97869820 not registered Live/Pending
Keeco, LLC
2023-04-03
TRILLIUM
TRILLIUM
90201101 not registered Live/Pending
Charles River Laboratories, Inc.
2020-09-22
TRILLIUM
TRILLIUM
90130460 not registered Live/Pending
Zumiez Services Inc.
2020-08-21
TRILLIUM
TRILLIUM
88862551 not registered Live/Pending
Microbial Biological Fertilizer International LLC
2020-04-07
TRILLIUM
TRILLIUM
88853105 not registered Live/Pending
The Miracle, LLC
2020-03-30
TRILLIUM
TRILLIUM
88650237 not registered Live/Pending
Feeney, Inc.
2019-10-10
TRILLIUM
TRILLIUM
88121569 5697422 Live/Registered
Trillium Herbal Company, Inc.
2018-09-18
TRILLIUM
TRILLIUM
88078993 not registered Live/Pending
Misig Inc.
2018-08-15
TRILLIUM
TRILLIUM
87765265 not registered Live/Pending
Trojan Battery Company, LLC
2018-01-22
TRILLIUM
TRILLIUM
87742092 5694633 Live/Registered
Trillium Incorporated
2018-01-03

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