ANTENNA 37092 EXT ULTRA US MKT Medical Device Identification

GUDID 00613994348661

ANTENNA 37092 EXT ULTRA US MKT

MEDTRONIC, INC.

Active-implantable-device communicator

Primary Device ID	00613994348661
NIH Device Record Key	0a16bde7-2363-4214-950f-9e68aacae6e5
Commercial Distribution Status	In Commercial Distribution
Version Model Number	37092
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	true
Serial Number	false
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

Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994348661 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

H020007

FDA Product Code

MHY	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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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