PhotoFix N/A

GUDID B040PFP6X81

Decellularized Bovine Pericardium

GENESEE BIOMEDICAL, INC.

Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived

• Primary Device ID: B040PFP6X81
• NIH Device Record Key: 73869f95-0ea8-41ce-a380-3941cdca297c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PhotoFix
• Version Model Number: PFP6x8
• Catalog Number: N/A
• Company DUNS: 939872651
• Company Name: GENESEE BIOMEDICAL, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• 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: 303 777-3000
• Email: info@geneseebiomedical.com
• Phone: 303 777-3000
• Email: info@geneseebiomedical.com
• Phone: 303 777-3000
• Email: info@geneseebiomedical.com
• Phone: 303 777-3000
• Email: info@geneseebiomedical.com
• Phone: 303 777-3000
• Email: info@geneseebiomedical.com
• Phone: 303 777-3000
• Email: info@geneseebiomedical.com
• Phone: 303 777-3000
• Email: info@geneseebiomedical.com
• Phone: 303 777-3000
• Email: info@geneseebiomedical.com
• Phone: 303 777-3000
• Email: info@geneseebiomedical.com
• Phone: 303 777-3000
• Email: info@geneseebiomedical.com
• Phone: 303 777-3000
• Email: info@geneseebiomedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B040PFP6X81 [Primary]

FDA Product Code

• DXZ: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-02-01

Devices Manufactured by GENESEE BIOMEDICAL, INC.

• B040WF26 - WellForm Tricuspid Annuloplasty Band: 2023-10-10 Annuloplasty Band
• B040WF28 - WellsForm Tricuspid Annuloplasty Band: 2023-10-10 Annuloplasty Band
• B040WF30 - WellsForm Tricuspid Annuloplasty Band: 2023-10-10 Annuloplasty Band
• B040WF32 - WellsFormTricuspid Annuloplasty Band: 2023-10-10 Annuloplasty Band
• B040WF34 - WellsForm Tricuspid Annuloplasty Band: 2023-10-10 Annuloplasty Band
• B040WF360 - WellsForm Tricuspid Annuloplasty Band: 2023-10-10 Annuloplasty Band
• B0404200260 - NeoForm: 2019-05-30 Annuloplasty Ring
• B040420028 - NeoForm: 2019-05-30 Annuloplasty Ring