GUDID 00763000875695

PRGM 8835-RFB PERSONAL THRPY MG2 RFRB US

MEDTRONIC, INC.

Infusion pump programmer
Primary Device ID00763000875695
NIH Device Record Key693755e5-cf68-4df4-b2aa-1f241aad8df2
Commercial Distribution StatusIn Commercial Distribution
Version Model Number8835-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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000875695 [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 Date2023-11-24
Device Publish Date2023-11-16

Devices Manufactured by MEDTRONIC, INC.

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