GUDID 20613994518853

ACCESS 040618 ANTENNA TAPE PATCH GLOBAL

MEDTRONIC, INC.

Hypoallergenic skin adhesive tape
Primary Device ID20613994518853
NIH Device Record Key7f756b6c-7545-44f5-8f19-e18f8a2121ab
Commercial Distribution StatusIn Commercial Distribution
Version Model Number040618
Company DUNS796986144
Company NameMEDTRONIC, INC.
Device Count50
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 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
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

Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994518859 [Unit of Use]
GS120613994518853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KGXTape and bandage, adhesive
LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-23
Device Publish Date2014-09-23

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