PROG FA37742 RX1 PATIENT FXD ASSET CLNC Medical Device Identification

GUDID 00885074384528

PROG FA37742 RX1 PATIENT FXD ASSET CLNC

MEDTRONIC, INC.

Active-implantable-device communicator Active-implantable-device communicator 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 ID	00885074384528
NIH Device Record Key	f7a38174-f7d5-4bd1-818d-0ba193ae080e
Commercial Distribution Status	In Commercial Distribution
Version Model Number	FA37742
Company DUNS	796986144
Company Name	MEDTRONIC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885074384528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P840001

FDA Product Code

LGW	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2014-09-23

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