Export Advance™

GUDID 00643169647343

CATH ADVANCE ASPIR EXPORT ADVANCE NSR

MEDTRONIC, INC.

Thrombectomy suction catheter
Primary Device ID00643169647343
NIH Device Record Keyfbc35385-853d-4a6c-b5b9-73b9dfc17dd5
Commercial Distribution StatusIn Commercial Distribution
Brand NameExport Advance™
Version Model NumberADVANCE
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 Perscriptionfalse
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
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

Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French
Length140 Centimeter
Lumen/Inner Diameter1.78 Millimeter
Catheter Gauge6 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store catheters in a cool, dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169647343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXECatheter, embolectomy
KRACatheter, continuous flush

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-11
Device Publish Date2016-09-23

Devices Manufactured by MEDTRONIC, INC.

00763000973506 - Sphere-9™ Catheter2025-01-21 CATHETER AFR-00001 SPHERE 9 US
00763000835392 - HawkOne™2025-01-06 ATHERECTOMY H1-14550 CUTTER DRIVER UNI
00763000989224 - NA2025-01-06 CUSTOM PACK BB12B64R6 GOLD H/L PACK
00763000990060 - NA2025-01-06 CUSTOM PACK BB12M44R UMCEP SHUNT PK
20763000990088 - NA2025-01-06 CUSTOM PACK 9D70R2 10PK HDR PK
20763000990460 - NA2025-01-06 CUSTOM PACK BB12M56R 10PK 1/4 SUPPLEMENT
20763000990484 - NA2025-01-06 CUSTOM PACK BB12M39R 2PK PACK C STRAIGH
20763000990507 - NA2025-01-06 CUSTOM PACK 11C82R1 4PK CARDIOPLEG

Trademark Results [Export Advance]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EXPORT ADVANCE
EXPORT ADVANCE
85740841 4415942 Live/Registered
Medtronic Vascular, Inc.
2012-09-28
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.