AccessGUDID - DEVICE: SJM™ Masters Series (05414734053884)

GUDID

Device Identifier (DI) Information

Brand Name: SJM™ Masters Series
Version or Model: 21AECJ-502
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 21AECJ-502
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05414734053884
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use

Device Description: Aortic Expanded Rotatable Mechanical Heart Valve

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 [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Store valve in cool, dry area until needed

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 21 Millimeter

Device Record Status

Public Device Record Key: b31c50ec-f7f0-4d72-808c-643d837ccdc7
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: September 23, 2014