Open Pivot™

GUDID 00763000198978

AVG 502AG21 US

MEDTRONIC, INC.

Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft
Primary Device ID00763000198978
NIH Device Record Key0c09ec35-1098-4eb4-82ff-d0c7776d1fb8
Commercial Distribution StatusIn Commercial Distribution
Brand NameOpen Pivot™
Version Model Number502AG21
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
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

Lumen/Inner Diameter21 Millimeter
Lumen/Inner Diameter21 Millimeter
Lumen/Inner Diameter21 Millimeter
Lumen/Inner Diameter21 Millimeter
Lumen/Inner Diameter21 Millimeter
Lumen/Inner Diameter21 Millimeter
Lumen/Inner Diameter21 Millimeter
Lumen/Inner Diameter21 Millimeter
Lumen/Inner Diameter21 Millimeter
Lumen/Inner Diameter21 Millimeter
Lumen/Inner Diameter21 Millimeter
Lumen/Inner Diameter21 Millimeter
Lumen/Inner Diameter21 Millimeter
Lumen/Inner Diameter21 Millimeter
Lumen/Inner Diameter21 Millimeter
Lumen/Inner Diameter21 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to temperatures greater than 50°C (122°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to temperatures greater than 50°C (122°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to temperatures greater than 50°C (122°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to temperatures greater than 50°C (122°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to temperatures greater than 50°C (122°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to temperatures greater than 50°C (122°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to temperatures greater than 50°C (122°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to temperatures greater than 50°C (122°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to temperatures greater than 50°C (122°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to temperatures greater than 50°C (122°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to temperatures greater than 50°C (122°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to temperatures greater than 50°C (122°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to temperatures greater than 50°C (122°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to temperatures greater than 50°C (122°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to temperatures greater than 50°C (122°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to temperatures greater than 50°C (122°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry location.

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000198978 [Primary]
GS100763000198978 [Primary]
GS100763000198978 [Primary]
GS100763000198978 [Primary]
GS100763000198978 [Primary]
GS100763000198978 [Primary]
GS100763000198978 [Primary]
GS100763000198978 [Primary]
GS100763000198978 [Primary]
GS100763000198978 [Primary]
GS100763000198978 [Primary]
GS100763000198978 [Primary]
GS100763000198978 [Primary]
GS100763000198978 [Primary]
GS100763000198978 [Primary]
GS100763000198978 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWQHEART-VALVE, MECHANICAL
LWQHEART-VALVE, MECHANICAL
LWQHEART-VALVE, MECHANICAL
LWQHEART-VALVE, MECHANICAL
LWQHEART-VALVE, MECHANICAL
LWQHEART-VALVE, MECHANICAL
LWQHEART-VALVE, MECHANICAL
LWQHEART-VALVE, MECHANICAL
LWQHEART-VALVE, MECHANICAL
LWQHEART-VALVE, MECHANICAL
LWQHEART-VALVE, MECHANICAL
LWQHEART-VALVE, MECHANICAL
LWQHEART-VALVE, MECHANICAL
LWQHEART-VALVE, MECHANICAL
LWQHEART-VALVE, MECHANICAL
LWQHEART-VALVE, MECHANICAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-22
Device Publish Date2021-02-13

On-Brand Devices [Open Pivot™]

00613994869050MHV 500DM35 STD MITRAL
00613994869043MHV 500FA29 STD AORTIC
00613994869036MHV 500FA27 STD AORTIC
00613994869029MHV 500FA25 STD AORTIC
00613994869012MHV 500FA23 STD AORTIC
00613994869005MHV 500FA21 STD AORTIC
00613994868992MHV 500FA19 STD AORTIC
00613994868985MHV 500DM31 STD MITRAL
00613994868978MHV 500DM29 STD MITRAL
00613994868961MHV 500DM27 STD MITRAL
00613994868954MHV 501DA16 AP AORTIC
00613994868947MHV 500DM33 STD MITRAL
00613994868930MHV 500DM31 STD MITRAL
00613994868923MHV 500DM29 STD MITRAL
00613994868916MHV 500DM27 STD MITRAL
00613994868893MHV 505DA26 AP360
00613994868886MHV 505DA24 AP360
00613994868879MHV 505DA22 AP360
00613994868862MHV 505DA20 AP360
00613994868855MHV 505DA18 AP360
00613994868848MHV 505DA16 AP360
00613994868800MHV 501DA18 AP AORTIC
00613994868794MHV 500DM25 STD MITRAL
00613994868787MHV 500FA29 STD AORTIC
00613994868770MHV 500FA27 STD AORTIC
00613994868756MHV 500FA23 STD AORTIC
00613994868749MHV 500FA21 STD AORTIC
00613994868732MHV 500FA19 STD AORTIC
00613994868725MHV 501DM28 AP MITRAL
00613994868718MHV 501DM26 AP MITRAL
00613994868701MHV 501DM24 AP MITRAL
00613994868695MHV 501DM22 AP MITRAL
00613994868688MHV 501DA26 AP AORTIC
00613994868671MHV 501DA24 AP AORTIC
00613994868664MHV 501DA22 AP AORTIC
00613994868657MHV 501DA20 AP AORTIC
00613994868633MHV 503DA26 APEX AORTIC
00613994868626MHV 503DA24 APEX AORTIC
00613994868619MHV 503DA22 APEX AORTIC
00613994868602MHV 503DA20 APEX AORTIC
00613994868596MHV 503DA18 APEX AORTIC
00613994868589MHV 503DA16 APEX AORTIC
00613994868374AVG 502AG29 CONDUIT
00613994868367AVG 502AG27 CONDUIT
00613994868350AVG 502AG25 CONDUIT
00613994868343AVG 502AG23 CONDUIT
00613994868336AVG 502AG21 CONDUIT
00643169133464AVG 502AG21 CONDUIT
00643169133457AVG 502AG23 CONDUIT
00643169133440AVG 502AG25 CONDUIT

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