FlexForm Annuloplasty Band

GUDID B040FBH30

Annuloplasty Band

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 Mitral/tricuspid annuloplasty ring

• Primary Device ID: B040FBH30
• NIH Device Record Key: 7022fe1e-a2b2-4b85-b19f-ec9a941086de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexForm Annuloplasty Band
• Version Model Number: FBH-30
• 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: true
• 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
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B040FBH30 [Package]; Contains: B040FBH300; Package: [1 Units]; In Commercial Distribution
HIBCC	B040FBH300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161815

FDA Product Code

• KRH: Ring, Annuloplasty

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-02

On-Brand Devices [FlexForm Annuloplasty Band]

• B040FBN40: Annuloplasty Band
• B040FBN38: Annuloplasty Band
• B040FBN36: Annuloplasty Band
• B040FBN34: Annuloplasty Band
• B040FBN320: Annuloplasty Band
• B040FBN30: Annuloplasty Band
• B040FBN28: Annuloplasty Band
• B040FBN26: Annuloplasty Band
• B040FBN24: Annuloplasty Band
• B040FBH40: Annuloplasty Band
• B040FBH38: Annuloplasty Band
• B040FBH36: Annuloplasty Band
• B040FBH34: Annuloplasty Band
• B040FBH32: Annuloplasty Band
• B040FBH30: Annuloplasty Band
• B040FBH28: Annuloplasty Band
• B040FBH26: Annuloplasty Band
• B040FBH24: Annuloplasty Band