GUDID 00643169974791

PROG 8835 PERSONAL THERAPY MGR GRC

MEDTRONIC, INC.

Infusion pump programmer
Primary Device ID00643169974791
NIH Device Record Key81203edf-0c9f-4f1a-b9df-98d130c9b566
Commercial Distribution StatusIn Commercial Distribution
Version Model Number8835
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169974791 [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 Date2018-09-11
Device Publish Date2018-08-11

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