AccessGUDID - DEVICE: Open Pivot™ (00613994960412)

GUDID

Device Identifier (DI) Information

Brand Name: Open Pivot™
Version or Model: 500FA23
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00613994960412
Issuing Agency: GS1
Commercial Distribution End Date: October 21, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: MHV 500FA23 STD AORTIC

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):	Yes
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?
60240	Aortic bi-leaflet mechanical heart valve prosthesis	An artificial substitute for a natural aortic heart valve intended to be implanted during open heart surgery typically to treat acquired or congenital valvular disease. It consists of two flat, semicircular, pyrolytic carbon-coated or polymer leaflets that pivot about pyrolytic carbon or metal struts attached to the valve housing by hinges; the hinge points intersect the valve lumen resulting in a total of three openings. When pressurized blood hits the valve, the two halves of the circle fold away from the valve ring and allow blood to flow into the three openings before the valve flaps close again.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LWQ	HEART-VALVE, MECHANICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P990046	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: less than 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Tissue Annulus 23 MM

Device Record Status

Public Device Record Key: da4c7a8f-265f-400e-a456-f8cb10c7fee4
Public Version Date: September 13, 2022
Public Version Number: 5
DI Record Publish Date: September 23, 2014