EverFlex™

GUDID 00821684051221

STENT EVD35-07-080-080 EF ENTRUST V01

Covidien LP

Multiple peripheral artery stent, bare-metal

Primary Device ID	00821684051221
NIH Device Record Key	71e88a9e-d26d-4849-9110-77a547c2527b
Commercial Distribution Status	In Commercial Distribution
Brand Name	EverFlex™
Version Model Number	EVD35-07-080-080
Company DUNS	968903703
Company Name	Covidien LP
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
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
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	80 Millimeter
Length	80 Millimeter
Length	80 Millimeter
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter
Catheter Gauge	5 French
Length	80 Millimeter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684051221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P110023

FDA Product Code

NIP	STENT, SUPERFICIAL FEMORAL ARTERY

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	2015-07-16

On-Brand Devices [EverFlex™]

00821684051795	STENT EVD35-08-150-150 EF ENTRUST V01
00821684051788	STENT EVD35-08-120-150 EF ENTRUST V01
00821684051771	STENT EVD35-08-100-150 EF ENTRUST V01
00821684051764	STENT EVD35-08-080-150 EF ENTRUST V01
00821684051757	STENT EVD35-08-060-150 EF ENTRUST V01
00821684051740	STENT EVD35-08-040-150 EF ENTRUST V01
00821684051733	STENT EVD35-08-020-150 EF ENTRUST V01
00821684051719	STENT EVD35-07-150-150 EF ENTRUST V01
00821684051702	STENT EVD35-07-120-150 EF ENTRUST V01
00821684051696	STENT EVD35-07-100-150 EF ENTRUST V01
00821684051689	STENT EVD35-07-080-150 EF ENTRUST V01
00821684051672	STENT EVD35-07-060-150 EF ENTRUST V01
00821684051665	STENT EVD35-07-040-150 EF ENTRUST V01
00821684051658	STENT EVD35-07-020-150 EF ENTRUST V01
00821684051634	STENT EVD35-06-150-150 EF ENTRUST V01
00821684051627	STENT EVD35-06-120-150 EF ENTRUST V01
00821684051610	STENT EVD35-06-100-150 EF ENTRUST V01
00821684051603	STENT EVD35-06-080-150 EF ENTRUST V01
00821684051597	STENT EVD35-06-060-150 EF ENTRUST V01
00821684051580	STENT EVD35-06-040-150 EF ENTRUST V01
00821684051573	STENT EVD35-06-020-150 EF ENTRUST V01
00821684051559	STENT EVD35-08-150-120 EF ENTRUST V01
00821684051542	STENT EVD35-08-120-120 EF ENTRUST V01
00821684051535	STENT EVD35-08-100-120 EF ENTRUST V01
00821684051528	STENT EVD35-08-080-120 EF ENTRUST V01
00821684051511	STENT EVD35-08-060-120 EF ENTRUST V01
00821684051504	STENT EVD35-08-040-120 EF ENTRUST V01
00821684051498	STENT EVD35-08-020-120 EF ENTRUST V01
00821684051474	STENT EVD35-07-150-120 EF ENTRUST V01
00821684051467	STENT EVD35-07-120-120 EF ENTRUST V01
00821684051450	STENT EVD35-07-100-120 EF ENTRUST V01
00821684051443	STENT EVD35-07-080-120 EF ENTRUST V01
00821684051436	STENT EVD35-07-060-120 EF ENTRUST V01
00821684051429	STENT EVD35-07-040-120 EF ENTRUST V01
00821684051412	STENT EVD35-07-020-120 EF ENTRUST V01
00821684051399	STENT EVD35-06-150-120 EF ENTRUST V01
00821684051382	STENT EVD35-06-120-120 EF ENTRUST V01
00821684051375	STENT EVD35-06-100-120 EF ENTRUST V01
00821684051368	STENT EVD35-06-080-120 EF ENTRUST V01
00821684051351	STENT EVD35-06-060-120 EF ENTRUST V01
00821684051344	STENT EVD35-06-040-120 EF ENTRUST V01
00821684051337	STENT EVD35-06-020-120 EF ENTRUST V01
00821684051320	STENT EVD35-08-150-080 EF ENTRUST V01
00821684051313	STENT EVD35-08-120-080 EF ENTRUST V01
00821684051306	STENT EVD35-08-100-080 EF ENTRUST V01
00821684051290	STENT EVD35-08-080-080 EF ENTRUST V01
00821684051283	STENT EVD35-08-060-080 EF ENTRUST V01
00821684051276	STENT EVD35-08-040-080 EF ENTRUST V01
00821684051269	STENT EVD35-08-020-080 EF ENTRUST V01
00821684051252	STENT EVD35-07-150-080 EF ENTRUST V01

Trademark Results [EverFlex]

Mark Image Registration \| Serial	Company Trademark Application Date
EVERFLEX 97549909 not registered Live/Pending	CornellCookson, LLC 2022-08-16
EVERFLEX 90206371 not registered Live/Pending	Hitachi Vantara LLC 2020-09-24
EVERFLEX 88631780 not registered Live/Pending	Maurices Incorporated 2019-09-26
EVERFLEX 87935879 not registered Live/Pending	C Products Defense, Inc. 2018-05-24
EVERFLEX 87878026 5717631 Live/Registered	teleMovement Physical Therapy, a Professional corporation 2018-04-16
EVERFLEX 86418474 4743484 Live/Registered	Ink Cups Now Corporation 2014-10-08
EVERFLEX 78803917 3270214 Live/Registered	COVIDIEN LP 2006-01-31
EVERFLEX 78004147 not registered Dead/Abandoned	MATTEL, INC. 2000-04-14
EVERFLEX 77600830 not registered Dead/Abandoned	Mohawk Brands, Inc. 2008-10-27
EVERFLEX 77004810 not registered Dead/Abandoned	Corinthian Colleges, Inc. 2006-09-21
EVERFLEX 76624977 not registered Dead/Abandoned	Foamorder.com, Inc. 2004-12-20
EVERFLEX 76520007 2917827 Live/Registered	Nature's Sunshine Products, Inc. 2003-06-05