Anastomark Coronary Artery Bypass Graft Markers, F

GUDID B040FMPM32

Coronary Artery Bypass Graft Markers, Flexible Proximal

GENESEE BIOMEDICAL, INC.

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• Primary Device ID: B040FMPM32
• NIH Device Record Key: 12e85959-f03c-4324-8a49-878643f45294
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anastomark Coronary Artery Bypass Graft Markers, F
• Version Model Number: FM-PM-3
• Company DUNS: 939872651
• Company Name: GENESEE BIOMEDICAL, INC.
• Device Count: 3
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B040FMPM3 [Unit of Use]
HIBCC	B040FMPM31 [Primary]
HIBCC	B040FMPM32 [Package]; Contains: B040FMPM31; Package: [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905067

FDA Product Code

• DSY: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

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: 2017-02-01

On-Brand Devices [Anastomark Coronary Artery Bypass Graft Markers, F]

• B040FMPM32: Coronary Artery Bypass Graft Markers, Flexible Proximal
• B040FMPM22: Coronary Artery Bypass Graft Markers, Flexible Proximal
• B040FMPM12: Coronary Artery Bypass Graft Markers, Flexible Proximal