GUDID 00763000446567

CUSTOM PACK CB11E15R3 PED AKRON

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set
Primary Device ID00763000446567
NIH Device Record Key0d74edce-c957-4e15-ae7d-ebf0e70cb6e5
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberCB11E15R3
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 Kittrue
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 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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000446567 [Primary]
GS100763000446567 [Primary]
GS100763000446567 [Primary]
GS100763000446567 [Primary]
GS100763000446567 [Primary]
GS100763000446567 [Primary]
GS100763000446567 [Primary]
GS100763000446567 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass
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 Date2020-11-09
Device Publish Date2020-10-31

Devices Manufactured by MEDTRONIC, INC.

00763000451738 - NA2020-12-04 CUSTOM PACK BB7H95R25 HYP MAIN1
00763000458249 - NA2020-12-04 CUSTOM PACK CB8J72R9 TABLE
00763000463564 - NA2020-12-04 CUSTOM PACK BB7P36R14 PEDIATRIC
20763000465692 - NA2020-12-04 CUSTOM PACK BB7C25R2 5PK SUCKER LN
00763000465810 - NA2020-12-04 CUSTOM PACK CB7N00R5 E 3/8
00763000465834 - NA2020-12-04 CUSTOM PACK HY10P31R19 WILSN ME
00763000465858 - NA2020-12-04 CUSTOM PACK BB11G71R3 HEAD PK
00763000178093 - Cobalt™ XT HF Quad CRT-D MRI SureScan™2020-11-30 CRTD DTPA2QQ COBALT XT HF QUAD MRI DF4

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.