ACCESS 6177 10BX STERILE RF HEAD COVER Medical Device Identification

GUDID 10681490142653

ACCESS 6177 10BX STERILE RF HEAD COVER

MEDTRONIC, INC.

Cable/lead/sensor/probe cover, sterile

Primary Device ID	10681490142653
NIH Device Record Key	6c308c9c-0ade-4569-a008-67de8c1d995d
Commercial Distribution Status	In Commercial Distribution
Version Model Number	6177
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

Device Dimensions

Length	120 Inch
Length	120 Inch
Length	120 Inch
Length	120 Inch
Length	120 Inch
Length	120 Inch
Length	120 Inch
Length	120 Inch
Length	120 Inch
Length	120 Inch
Length	120 Inch
Length	120 Inch
Length	120 Inch
Length	120 Inch
Length	120 Inch
Length	120 Inch
Length	120 Inch
Length	120 Inch

Operating and Storage Conditions

Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681490142656 [Primary]
GS1	10681490142653 [Package] Contains: 00681490142656 Package: PK [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P890003

FDA Product Code

OSR	Pacemaker/icd/crt non-implanted components

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

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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