CABLE ACHIEVE ADVANCE 10-PIN Medical Device Identification

GUDID 00643169636644

CABLE ACHIEVE ADVANCE 10-PIN

MEDTRONIC, INC.

Cardiac mapping catheter, percutaneous, single-use

Primary Device ID	00643169636644
NIH Device Record Key	8bbf727e-0f7a-4bad-bf46-d3af4e7759aa
Commercial Distribution Status	In Commercial Distribution
Version Model Number	2ACHC
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
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Device Dimensions

Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	77 Inch
Length	1.96 Meter
Length	77 Inch
Length	1.96 Meter
Length	77 Inch
Length	1.96 Meter
Length	77 Inch
Length	1.96 Meter
Length	77 Inch
Length	1.96 Meter
Length	77 Inch
Length	1.96 Meter
Length	77 Inch
Length	1.96 Meter
Length	77 Inch
Length	1.96 Meter
Length	77 Inch
Length	1.96 Meter
Length	77 Inch
Length	1.96 Meter
Length	77 Inch
Length	1.96 Meter
Length	77 Inch
Length	1.96 Meter
Length	77 Inch
Length	1.96 Meter
Length	77 Inch
Length	1.96 Meter
Length	77 Inch
Length	1.96 Meter
Length	77 Inch
Length	1.96 Meter
Length	77 Inch
Length	1.96 Meter
Length	77 Inch
Length	1.96 Meter

Operating and Storage Conditions

Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169636644 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153139

FDA Product Code

DRF	CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2016-12-26

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