MC2®

GUDID 00643169159532

CANN CB91236 MC2 36/46FR 17L

MEDTRONIC, INC.

Cardiopulmonary bypass cannula, venous
Primary Device ID00643169159532
NIH Device Record Key8768458d-2908-4e3f-9f7b-8237d4563ceb
Commercial Distribution Discontinuation2018-10-05
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMC2®
Version Model NumberCB91236
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 Producttrue
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
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

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Device Size Text, specify0
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Device Size Text, specify0
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Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169159532 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-11
Device Publish Date2016-04-22

On-Brand Devices [MC2®]

20613994887416CANNULA 91265 MC2 VEN OVAL 36/46FR
00643169560550CANN CB91228C MC2 VEN 28/36F CON 17
00643169560543CANN CB91228 MC2 VEN 28/36FR 17L
00643169560536CANN CB91329C MC2 VEN 29/29FR 17L
00643169560529CANN CB91329 MC2 VEN 29/29FR 17L
20643169463060CANNULA 91229C MC2 VEN 29/37FR 10PK 17L
20643169463053CANNULA 91229 MC2 VEN 29/37FR 10PK 17L
20643169463046CANNULA 91228C MC2 VEN 28/36F CON 10P 17
20643169463039CANNULA 91329 MC2 VEN 29/29FR 10PK 17L
20643169463015CANNULA 91228 MC2 VEN 28/36FR 10PK 17L
20643169463008CANNULA 91329C MC2 VEN 29/29FR 10PK 17L
00643169159891CANN CB91329 MC2 29/29FR 17L
00643169159884CANN CB91265C MC2 OV 36/46F 17
00643169159877CANN CB91265 MC2 OV 36/46F 17L
00643169159860CANN CB91263C MC2 OV 32/40F 17
00643169159853CANN CB91263 MC2 OV 32/40F 17L
00643169159846CANN CB91251C MC2 36/51FR 17L
00643169159839CANN CB91251 MC2 36/51FR 17L
00643169159822CANN CB91246C MC2 34/46FR 17L
00643169159815CANN CB91246 MC2 34/46FR 17L
00643169159808CANN CB91240C MC2 32/40FR 17L
00643169159792CANN CB91240 MC2 32/40FR 17L
00643169159549CANN CB91236C MC2 36/46FR 17L
00643169159532CANN CB91236 MC2 36/46FR 17L
00643169159525CANN CB91228C MC2 28/36FR 17L
00643169159242CANN CB91329C MC2 29/29FR 17L
20613994887539CANNULA 91246 MC2 VEN 34/46FR 10PK 17L
20613994887522CANNULA 91246C MC2 VEN 34/46F CON 10P 17
20613994887492CANNULA 91251 MC2 VEN 36/51FR 10PK 17L
20613994887485CANNULA 91251C MC2 VEN 36/51F CON 10P 17
20613994887454CANNULA 91263 MC2 VEN OVAL 32/40FR 10P
20613994887447CANNULA 91263C MC2 VEN OVAL 32/40FR CON
20613994887409CANNULA 91228 MC2 VEN 28/36FR 10PK 17L
20613994887355CANNULA 91236 MC2 VEN 36/46FR 10PK 17L
20613994887348CANNULA 91236C MC2 VEN 36/46F CON 10P 17
20613994887317CANNULA 91240 MC2 VEN 32/40FR 10PK 17L
20613994887300CANNULA 91240C MC2 VEN 32/40F CON 10P 17
20613994887140CANNULA 91265C MC2 VEN OVAL 36/46FR CON
20613994887102CANNULA 91329C MC2 VEN 29/29F CON 10P 17

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