FREESTYLE®

GUDID 00681490219112

VALVE 995CS23 FREESTYLE CS US

MEDTRONIC, INC.

Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis
Primary Device ID00681490219112
NIH Device Record Key75f3afe3-cc2f-4193-8909-95ab5990e531
Commercial Distribution Discontinuation2017-11-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameFREESTYLE®
Version Model Number995CS23
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
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

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

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100681490219112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWRheart-valve, non-allograft tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-23

On-Brand Devices [FREESTYLE®]

00613994348982VALVE FR995-29 FREESTYLE US NNA
00613994348975VALVE FR995-27 FREESTYLE US NNA
00643169008144VLV FR995-29 FREESTYLE AOR US TEMP IND
00643169008137VLV FR995-27 FREESTYLE AOR US TEMP IND
00643169002418VLV 995MS21 FREESTYLE MS US TEMP IND
00643169002395VLV 995MS19 FREESTYLE MS US TEMP IND
00643169002302VLV 995CS27 FREESTYLE CS US TEMP IND
00643169002289VLV 995CS25 FREESTYLE CS US TEMP IND
00643169002265VLV 995CS23 FREESTYLE CS US TEMP IND
00643169002241VLV 995CS21 FREESTYLE CS US TEMP IND
00643169002227VLV 995CS19 FREESTYLE CS US TEMP IND
00643169002197VLV FR995-29 FREESTYLE AOR NNA US TEMP I
00643169002173VLV FR995-27 FREESTYLE AOR NNA US TEMP I
00643169002159VLV FR995-25 FREESTYLE AOR US TEMP IND
00643169002135VLV FR995-23 FREESTYLE AOR US TEMP IND
00643169002111VLV FR995-21 FREESTYLE AOR US TEMP IND
00643169002098VLV FR995-19 FREESTYLE AOR US TEMP IND
00643169002074VLV 995MS29 FREESTYLE MS US TEMP IND
00643169002050VLV 995MS27 FREESTYLE MS US TEMP IND
00643169002036VLV 995MS25 FREESTYLE MS US TEMP IND
00643169002012VLV 995MS23 FREESTYLE MS US TEMP IND
00681490816465VALVE FR995-29 FREESTYLE AOR US
00681490265942VALVE FR995-27 FREESTYLE AOR US
00681490265904VALVE FR995-23 FREESTYLE AOR US
00681490265898VALVE FR995-21 FREESTYLE AOR US
00681490219198VALVE 995CS27 FREESTYLE CS US
00681490219150VALVE 995CS25 FREESTYLE CS US
00681490219112VALVE 995CS23 FREESTYLE CS US
00681490219075VALVE 995CS21 FREESTYLE CS US
00681490219037VALVE 995CS19 FREESTYLE CS US
00721902316197VALVE 995MS29 FREESTYLE MS US
00721902316180VALVE 995MS27 FREESTYLE MS US
00721902316173VALVE 995MS25 FREESTYLE MS US
00721902316166VALVE 995MS23 FREESTYLE MS US
00721902316159VALVE 995MS21 FREESTYLE MS US
00721902316142VALVE 995MS19 FREESTYLE MS US
10681490265918VALVE FR99525 FREESTYLE AOR US
10681490265888VALVE FR995-19 FREESTYLE AOR US

Trademark Results [FREESTYLE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FREESTYLE
FREESTYLE
98281125 not registered Live/Pending
Freestyle Software Inc.
2023-11-21
FREESTYLE
FREESTYLE
98220292 not registered Live/Pending
AUGUSTA SPORTSWEAR, INC.
2023-10-12
FREESTYLE
FREESTYLE
97601152 not registered Live/Pending
Mimetics Inc.
2022-09-21
FREESTYLE
FREESTYLE
97353950 not registered Live/Pending
Benjamin B. Ryan
2022-04-08
FREESTYLE
FREESTYLE
97108607 not registered Live/Pending
Nor'wood Limited, Inc.
2021-11-04
FREESTYLE
FREESTYLE
97102656 not registered Live/Pending
Somnetics International, Inc.
2021-11-01
FREESTYLE
FREESTYLE
97017205 not registered Live/Pending
Hebe Studio Ltd.
2021-09-08
FREESTYLE
FREESTYLE
90980881 not registered Live/Pending
Real Big Waves LLC
2020-10-21
FREESTYLE
FREESTYLE
90978857 not registered Live/Pending
Dad Provisions, Inc.
2021-07-28
FREESTYLE
FREESTYLE
90853142 not registered Live/Pending
Dad Provisions, Inc.
2021-07-28
FREESTYLE
FREESTYLE
90764538 not registered Live/Pending
Firebox Outdoors, LLC
2021-06-09
FREESTYLE
FREESTYLE
90562471 not registered Live/Pending
American International Relocation Solutions, LLC
2021-03-05

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