Arctic Front Advance Pro™

GUDID 00643169889903

CATH AFAPRO28 AFA PRO 28 US

MEDTRONIC, INC.

Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter
Primary Device ID00643169889903
NIH Device Record Key80dad3a3-3ffa-4f00-8d24-f70f66bd996f
Commercial Distribution StatusIn Commercial Distribution
Brand NameArctic Front Advance Pro™
Version Model NumberAFAPRO28
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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
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

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
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
GS100643169889903 [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 Date2019-02-21
Device Publish Date2019-01-21

On-Brand Devices [Arctic Front Advance Pro™]

00643169889903CATH AFAPRO28 AFA PRO 28 US
00643169889880CATH AFAPRO23 AFA PRO 23 US
00763000197766CATH AFAPRO23 AFA PRO 23 US PB
00763000088637CATH AFAPRO28 AFA PRO 28MM US PB
00763000245436CATH AFAPRO28 AFA PRO 28 US
00763000245412CATH AFAPRO23 AFA PRO 23 US
00763000341503CATH AFAPRO28 AFA PRO 28 US MVC
00763000341497CATH AFAPRO23 AFA PRO 23 US MVC
00763000431464CATH AFAPRO28 AFA PRO 28 US
00763000431457CATH AFAPRO23 AFA PRO 23 US PB
00763000707781CATH AFAPRO28 AFA PRO 28 US MVC
00763000707774CATH AFAPRO23 AFA PRO 23 US MVC

Trademark Results [Arctic Front Advance Pro]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ARCTIC FRONT ADVANCE PRO
ARCTIC FRONT ADVANCE PRO
87144212 5728288 Live/Registered
Medtronic Cryocath LP
2016-08-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.