MC2™

GUDID 00763000193102

CANN CB91263 MC2 OVAL 32/40F

MEDTRONIC, INC.

Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous
Primary Device ID00763000193102
NIH Device Record Keyd8d63c84-0680-4bef-b7e2-d6517325366e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMC2™
Version Model NumberCB91263
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

Device Dimensions

Catheter Gauge32 French
Catheter Gauge40 French
Catheter Gauge32 French
Catheter Gauge40 French
Catheter Gauge32 French
Catheter Gauge40 French
Catheter Gauge32 French
Catheter Gauge40 French
Catheter Gauge32 French
Catheter Gauge40 French
Catheter Gauge32 French
Catheter Gauge40 French
Catheter Gauge32 French
Catheter Gauge40 French
Catheter Gauge32 French
Catheter Gauge40 French
Catheter Gauge32 French
Catheter Gauge40 French
Catheter Gauge32 French
Catheter Gauge40 French
Catheter Gauge32 French
Catheter Gauge40 French
Catheter Gauge32 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000193102 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-14
Device Publish Date2019-03-06

On-Brand Devices [MC2™]

00643169696952CANNULA CB91329C MC2 VEN 29/29F CON 17
00643169696945CANN CB91329 MC2 29/29FR 17L
00643169696938CANN CB91265C MC2 36/46FR CON
00643169696921CANN CB91265 MC2 VEN 36/46FR
00643169696914CANN CB91263C MC2 OV 32/40F 17
00643169696907CANN CB91263 MC2 OVAL 32/40F
00643169696891CANNULA CB91251C MC2 VEN 36/51F CON 17
00643169696884CANNULA CB91246C MC2 VEN 34/46F CON 17
00643169696877CANN CB91246 MC2 34/46FR 17L
00643169696860CANNULA CB91240C MC2 VEN 32/40F CON 17
00643169696853CANN CB91240 MC2 32/40FR 17L
00643169696846CANN CB91236C MC2 36/46F 17L
00643169696839CANN CB91228C MC2 28/36FR 17L
00643169696822CANN CB91228 MC2 28/36FR 17L
00763000193157CANNULA CB91329C MC2 VEN 29/29F CON 17
00763000193140CANN CB91329 MC2 29/29FR 17L
00763000193133CANN CB91265C MC2 36/46FR CON
00763000193126CANN CB91265 MC2 VEN 36/46FR
00763000193119CANN CB91263C MC2 OV 32/40F 17
00763000193102CANN CB91263 MC2 OVAL 32/40F
00763000193096CANNULA CB91246C MC2 VEN 34/46F CON 17
00763000193089CANN CB91246 MC2 34/46FR 17L
00763000193072CANNULA CB91240C MC2 VEN 32/40F CON 17
00763000193065CANN CB91240 MC2 32/40FR 17L
00763000193058CANN CB91236C MC2 36/46F 17L
00763000193041CANN CB91228C MC2 28/36FR 17L
00763000193034CANN CB91228 MC2 28/36FR 17L
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.