GUDID 20763000446516

CUSTOM PACK BB11J14R2 5PK BRIDGE

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 ID20763000446516
NIH Device Record Key8fa7810f-ddc6-4a83-81dd-14cd19c57e52
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberBB11J14R2
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 Productfalse
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 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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
GS100763000446505 [Primary]
GS100763000446505 [Primary]
GS100763000446505 [Primary]
GS100763000446505 [Primary]
GS100763000446505 [Primary]
GS100763000446505 [Primary]
GS100763000446505 [Primary]
GS100763000446505 [Primary]
GS120763000446516 [Package]
Contains: 00763000446505
Package: PK [5 Units]
In Commercial Distribution
GS120763000446516 [Package]
Contains: 00763000446505
Package: PK [5 Units]
In Commercial Distribution
GS120763000446516 [Package]
Contains: 00763000446505
Package: PK [5 Units]
In Commercial Distribution
GS120763000446516 [Package]
Contains: 00763000446505
Package: PK [5 Units]
In Commercial Distribution
GS120763000446516 [Package]
Contains: 00763000446505
Package: PK [5 Units]
In Commercial Distribution
GS120763000446516 [Package]
Contains: 00763000446505
Package: PK [5 Units]
In Commercial Distribution
GS120763000446516 [Package]
Contains: 00763000446505
Package: PK [5 Units]
In Commercial Distribution
GS120763000446516 [Package]
Contains: 00763000446505
Package: PK [5 Units]
In Commercial Distribution

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.

00763000447236 - NA2020-11-10 CUSTOM PACK BB9S37R7 ADULT EV
20763000447377 - NA2020-11-10 CUSTOM PACK BB8N87R3 5PK ARTERIAL Y
20763000447407 - NA2020-11-10 CUSTOM PACK BB11M96R 4PK 1/4-4/1
20763000448312 - NA2020-11-10 CUSTOM PACK BB9D19R2 5PK ACCS PK
00643169796157 - Abre™2020-11-09 STENT AB9U10040090 ABRE V01
00643169796164 - Abre™2020-11-09 STENT AB9U10060090 ABRE V01
00643169796171 - Abre™2020-11-09 STENT AB9U10080090 ABRE V01
00643169796188 - Abre™2020-11-09 STENT AB9U10100090 ABRE V01

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