Affinity

GUDID 50613994010792

RESERVOIR 61399401079 AFFINITY 8CA VN321

MEDTRONIC, INC.

Cardiotomy reservoir
Primary Device ID50613994010792
NIH Device Record Keyf0a436e5-7e01-4e14-94a8-cf813cf5d0f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAffinity
Version Model Number61399401079
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count8
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

Operating and Storage Conditions

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
GS100613994010797 [Unit of Use]
GS150613994010792 [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 Date2016-09-24

Devices Manufactured by MEDTRONIC, INC.

20763000825380 - NA2024-11-20 CUSTOM PACK CB12B36R1 4PK DEL NIDO CPG
20763000984193 - NA2024-11-18 CUSTOM PACK BB12F71R5 4PK LOYOLA CPG
20763000982946 - NA2024-11-15 CUSTOM PACK BB12B46R2 10PK MANIFOLD
00763000984007 - NA2024-11-15 CUSTOM PACK BB12D88R6 UW HEART LUNG
00763000984021 - NA2024-11-15 CUSTOM PACK BB12H36R4 PUMP TABLE
00763000984151 - NA2024-11-15 CUSTOM PACK BB12F08R2 SPECTRUM ADLT
00763000984168 - NA2024-11-15 CUSTOM PACK BB12F26R4 MUNSTER FUS
00763000984175 - NA2024-11-15 CUSTOM PACK BB12F66R6 1/4 EC PACK

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

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