Affinity™

GUDID 00763000301330

HANDCRANK HC150A PLX 31L

MEDTRONIC, INC.

Centrifugal circulatory assist pump, manual Centrifugal circulatory assist pump, manual Centrifugal circulatory assist pump, manual Centrifugal circulatory assist pump, manual Centrifugal circulatory assist pump, manual Centrifugal circulatory assist pump, manual Centrifugal circulatory assist pump, manual Centrifugal circulatory assist pump, manual Centrifugal circulatory assist pump, manual Centrifugal circulatory assist pump, manual Centrifugal circulatory assist pump, manual Centrifugal circulatory assist pump, manual Centrifugal circulatory assist pump, manual Centrifugal circulatory assist pump, manual Centrifugal circulatory assist pump, manual
Primary Device ID00763000301330
NIH Device Record Keyc7c4ef1f-4103-4b2c-890a-d803a8b573d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAffinity™
Version Model NumberHC150A
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 Usefalse
Lot Batchfalse
Serial Numbertrue
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

Device Dimensions

Weight3.2 Kilogram
Weight3.2 Kilogram
Weight3.2 Kilogram
Weight3.2 Kilogram
Weight3.2 Kilogram
Weight3.2 Kilogram
Weight3.2 Kilogram
Weight3.2 Kilogram
Weight3.2 Kilogram
Weight3.2 Kilogram
Weight3.2 Kilogram
Weight3.2 Kilogram
Weight3.2 Kilogram
Weight3.2 Kilogram
Weight3.2 Kilogram

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 66 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000301330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWAControl, pump speed, cardiopulmonary bypass

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-08
Device Publish Date2020-05-31

On-Brand Devices [Affinity™]

20643169878116FILTER CB851 AF100 WITH CORTIVA 26L
20643169858910FILTER S4014 AFFINITYPEDIATRIC ART ST
20643169858842FILTER 61399409434 AFFINITY 6PK ARFIL20M
20643169858835FILTER 61399401124 AFFINITY 6PK ART 351
20643169767762FILTER 61399401153 AFFINITY 6CA ART 352
20643169767748FILTER 61399409503 AFFINITY ART 354 6PK
00643169745001HANDCRANK HC150A
00763000219628PROBE ATP210 AFFINITY TEMPERATURE
00643169272248ADAPTER AP40AST AFFINITY CP WW
00763000301330HANDCRANK HC150A PLX 31L
20763000134567PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC
20763000134550PUMP BBAP40 AFFINITY CP CENTRIFUGAL BC
20763000134536PUMP AP40 AFFINITY CP CENTRIFUGAL NC
00763000445744FINAL PACK ATP210 TEMP PROBE GBL

Trademark Results [Affinity]

Mark Image

Registration | Serial
Company
Trademark
Application Date
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
AFFINITY
AFFINITY
97041836 not registered Live/Pending
MacDermid, Incorporated
2021-09-23

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