NeoForm

GUDID B040420032

Annuloplasty Ring

GENESEE BIOMEDICAL, INC.

Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring

• Primary Device ID: B040420032
• NIH Device Record Key: 696d7435-6872-46c2-ae7d-1a461bfb046d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoForm
• Version Model Number: 4200-32
• Company DUNS: 939872651
• Company Name: GENESEE BIOMEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B040420032 [Package]; Contains: B0404200320; Package: [1 Units]; In Commercial Distribution
HIBCC	B0404200320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190506

FDA Product Code

• KRH: Ring, Annuloplasty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-30
• Device Publish Date: 2019-05-22

On-Brand Devices [NeoForm]

• B040420032: Annuloplasty Ring
• B040420030: Annuloplasty Ring
• B040420028: Annuloplasty Ring
• B0404200260: Annuloplasty Ring