Avalus Ultra™

GUDID 00763000647049

AVALUSTM ULTRA 400U23 23MM VALVE SIZE

MEDTRONIC, INC.

Aortic heart valve bioprosthesis
Primary Device ID00763000647049
NIH Device Record Keyb6272a4e-64e1-4cc1-9e46-9c89a493c7ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameAvalus Ultra™
Version Model Number400U23
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exempttrue
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000647049 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-13
Device Publish Date2024-05-04

On-Brand Devices [Avalus Ultra™]

00763000647094AVALUSTM ULTRA 7400SU SIZERS
00763000647070AVALUSTM ULTRA 400U29 29MM VALVE SIZE
00763000647063AVALUSTM ULTRA 400U27 27MM VALVE SIZE
00763000647056AVALUSTM ULTRA 400U25 25MM VALVE SIZE
00763000647049AVALUSTM ULTRA 400U23 23MM VALVE SIZE
00763000647032AVALUSTM ULTRA 400U21 21MM VALVE SIZE
00763000647025AVALUSTM ULTRA 400U19 19MM VALVE SIZE

Trademark Results [Avalus Ultra]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AVALUS ULTRA
AVALUS ULTRA
97747710 not registered Live/Pending
Medtronic, Inc
2023-01-10

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