Arctic Front Advance™

GUDID 00643169939271

CATHETER 2AF234 ARCTIC FRONT ADV US 23MM

MEDTRONIC, INC.

Cardiac cryosurgical system catheter
Primary Device ID00643169939271
NIH Device Record Key3712c2b0-9cc9-4000-a014-b6e345a482d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameArctic Front Advance™
Version Model Number2AF234
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Dimensions

Length95 Centimeter
Length95 Centimeter
Length95 Centimeter
Length95 Centimeter
Length95 Centimeter
Length95 Centimeter
Device Size Text, specify0
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Length95 Centimeter
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Device Size Text, specify0
Length95 Centimeter
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Device Size Text, specify0
Length95 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length95 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length95 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length95 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length95 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length95 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length95 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length95 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length95 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length95 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length95 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length95 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length95 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length95 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length95 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169939271 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-26
Device Publish Date2018-06-25

On-Brand Devices [Arctic Front Advance™]

00643169939318CATHETER 2AF284 ARCTIC FRONT ADV US 28MM
00643169939271CATHETER 2AF234 ARCTIC FRONT ADV US 23MM
00643169753693CATHETER 2AF284 ARCTIC FRONT ADV US 28MM
00643169753686CATHETER 2AF234 ARCTIC FRONT ADV US 23MM
00643169504783CATHETER 2AF284 ARCTIC FRONT ADV US 28MM
00643169345614CATHETER 2AF284 AFA US 28MM
00643169345591CATHETER 2AF234 AFA US 23MM
00643169976382CATHETER 2AF284 ARCTIC FRONT ADV US 28MM
00643169976368CATHETER 2AF234 ARCTIC FRONT ADV US 23MM
00643169878365CATHETER 2AF284 ARCTIC FRONT ADV US 28MM
00643169878327CATHETER 2AF234 ARCTIC FRONT ADV US 23MM
00763000341480CATH 2AF284 ARCTIC FRONT ADV US 28MM MVC
00763000341473CATH 2AF234 ARCTIC FRONT ADV US 23MM MVC
00763000431501CATHETER 2AF284 ARCTIC FRONT ADV US 28MM
00763000431488CATHETER 2AF234 ARCTIC FRONT ADV US 23MM
00763000431532CATH 2AF284 ARCTIC FRONT ADV US 28MM MVC
00763000431518CATH 2AF234 ARCTIC FRONT ADV US 23MM MVC

Trademark Results [Arctic Front Advance]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ARCTIC FRONT ADVANCE
ARCTIC FRONT ADVANCE
85476235 4388809 Live/Registered
Medtronic CryoCath LP
2011-11-18

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