GUDID 00763000875725

COMMUNICATOR 8880T2-RFB CLN CTM RFRB GRC

MEDTRONIC, INC.

Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer
Primary Device ID00763000875725
NIH Device Record Key35b7a22b-9fef-4b0c-9239-6f36036297f4
Commercial Distribution StatusIn Commercial Distribution
Version Model Number8880T2-RFB
Company DUNS796986144
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
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius
Storage Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween -35 Degrees Celsius and 58 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000875725 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKKPump, infusion, implanted, programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-18
Device Publish Date2023-12-09

Devices Manufactured by MEDTRONIC, INC.

20763000770291 - TrailBlazer™2024-07-16 PS ASC-014-090 TRAILBLAZER ANGLED V04
20763000770307 - TrailBlazer™2024-07-16 PS ASC-014-135 TRAILBLAZER ANGLED V04
20763000770314 - TrailBlazer™2024-07-16 PS ASC-014-150 TRAILBLAZER ANGLED V04
20763000770321 - TrailBlazer™2024-07-16 PS ASC-018-090 TRAILBLAZER ANGLED V04
20763000770338 - TrailBlazer™2024-07-16 PS ASC-018-135 TRAILBLAZER ANGLED V04
20763000770345 - TrailBlazer™2024-07-16 PS ASC-018-150 TRAILBLAZER ANGLED V04
20763000770352 - TrailBlazer™2024-07-16 PS ASC-035-065 TRAILBLAZER ANGLED V04
20763000770369 - TrailBlazer™2024-07-16 PS ASC-035-090 TRAILBLAZER ANGLED V04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.