Harmony™

GUDID 00763000338985

TPV HARMONY-22 COMM

MEDTRONIC, INC.

Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis Pulmonary transcatheter heart valve bioprosthesis
Primary Device ID00763000338985
NIH Device Record Keyfcae176a-4ea0-45c2-b68d-1847e602f13d
Commercial Distribution StatusIn Commercial Distribution
Brand NameHarmony™
Version Model NumberHARMONY-22
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 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

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the TPV at room temperature (5°C to 25°C [41°F to 77°F])
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the TPV at room temperature (5°C to 25°C [41°F to 77°F])
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the TPV at room temperature (5°C to 25°C [41°F to 77°F])
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the TPV at room temperature (5°C to 25°C [41°F to 77°F])
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the TPV at room temperature (5°C to 25°C [41°F to 77°F])
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the TPV at room temperature (5°C to 25°C [41°F to 77°F])
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the TPV at room temperature (5°C to 25°C [41°F to 77°F])
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the TPV at room temperature (5°C to 25°C [41°F to 77°F])
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the TPV at room temperature (5°C to 25°C [41°F to 77°F])
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the TPV at room temperature (5°C to 25°C [41°F to 77°F])
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the TPV at room temperature (5°C to 25°C [41°F to 77°F])
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the TPV at room temperature (5°C to 25°C [41°F to 77°F])
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the TPV at room temperature (5°C to 25°C [41°F to 77°F])
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the TPV at room temperature (5°C to 25°C [41°F to 77°F])
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the TPV at room temperature (5°C to 25°C [41°F to 77°F])
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the TPV at room temperature (5°C to 25°C [41°F to 77°F])

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000338985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPVPulmonary valve prosthesis percutaneously delivered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-30
Device Publish Date2021-04-22

On-Brand Devices [Harmony™]

00763000341367HARMONY" DELIVERY CATHETER SYSTEM
00763000338992TPV HARMONY-25 COMM
00763000338985TPV HARMONY-22 COMM

Trademark Results [Harmony]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HARMONY
HARMONY
98411273 not registered Live/Pending
Harmony AI, LLC
2024-02-19
HARMONY
HARMONY
98308738 not registered Live/Pending
Toon Boom Animation Inc.
2023-12-11
HARMONY
HARMONY
98148651 not registered Live/Pending
Agnetix, Inc.
2023-08-24
HARMONY
HARMONY
98083871 not registered Live/Pending
Society for Translational Oncology, Inc.
2023-07-13
HARMONY
HARMONY
98083857 not registered Live/Pending
Society for Translational Oncology, Inc.
2023-07-13
HARMONY
HARMONY
97900700 not registered Live/Pending
Owens-Illinois General Inc.
2023-04-21
HARMONY
HARMONY
97729470 not registered Live/Pending
New Leaf Paper, Inc.
2022-12-22
HARMONY
HARMONY
97669321 not registered Live/Pending
The Frozen Bean, Inc.
2022-11-09
HARMONY
HARMONY
97667359 not registered Live/Pending
The Frozen Bean, Inc.
2022-11-08
HARMONY
HARMONY
97652632 not registered Live/Pending
Music Care USA, Inc.
2022-10-28
HARMONY
HARMONY
97643599 not registered Live/Pending
Greenwood, Inc.
2022-10-22
HARMONY
HARMONY
97558451 not registered Live/Pending
Orthofix US LLC
2022-08-22

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