GUDID 00643169305120

COVER EPG 53922US 3 PK MKT US

MEDTRONIC, INC.

External pacemaker cover External pacemaker cover External pacemaker cover External pacemaker cover External pacemaker cover External pacemaker cover External pacemaker cover External pacemaker cover External pacemaker cover External pacemaker cover External pacemaker cover External pacemaker cover External pacemaker cover External pacemaker cover External pacemaker cover External pacemaker cover External pacemaker cover External pacemaker cover

Primary Device ID	00643169305120
NIH Device Record Key	7b5c67de-48ca-4b11-b19a-50eacd4e5e9a
Commercial Distribution Status	In Commercial Distribution
Version Model Number	53922US
Company DUNS	006261481
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	true
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

Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169305120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132924

FDA Product Code

DTE	PULSE-GENERATOR, PACEMAKER, EXTERNAL

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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