AccessGUDID - DEVICE: Harmony™ (00763000338992)

GUDID

Device Identifier (DI) Information

Brand Name: Harmony™
Version or Model: HARMONY-25
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00763000338992
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: TPV HARMONY-25 COMM

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60247	Pulmonary transcatheter heart valve bioprosthesis	An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed or regurgitant pulmonary heart valve prosthesis (previously implanted), or native pulmonary valve anatomy that may have been surgically repaired, and which is designed to be implanted with a catheter via vascular access. It may be attached to an expandable metal framework which may be expanded with a balloon or self-expand, and may include other material types (e.g., synthetic polymer). Devices associated with implantation (e.g., catheter, introducer) may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NPV	Pulmonary valve prosthesis percutaneously delivered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P200046	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Valve size 25 mm

Device Record Status

Public Device Record Key: b85ce223-64ac-4836-8e77-1ce6b6f864bb
Public Version Date: April 30, 2021
Public Version Number: 1
DI Record Publish Date: April 22, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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