FloraSeal Mini FS-035T

GUDID M495FS035T0

FloraSeal Mini Microbial Sealant

ADHEZION BIOMEDICAL, LLC

Surgical skin microbial sealant

• Primary Device ID: M495FS035T0
• NIH Device Record Key: b0a5547a-107c-407a-a723-a76a1e9d7561
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FloraSeal Mini
• Version Model Number: FS035T
• Catalog Number: FS-035T
• Company DUNS: 827716437
• Company Name: ADHEZION BIOMEDICAL, LLC
• Device Count: 12
• DM Exempt: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8287263791
• Email: jhuntsinger@adhezion.com
• Phone: 8287263791
• Email: jhuntsinger@adhezion.com
• Phone: 8287263791
• Email: jhuntsinger@adhezion.com
• Phone: 8287263791
• Email: jhuntsinger@adhezion.com
• Phone: 8287263791
• Email: jhuntsinger@adhezion.com
• Phone: 8287263791
• Email: jhuntsinger@adhezion.com
• Phone: 8287263791
• Email: jhuntsinger@adhezion.com
• Phone: 8287263791
• Email: jhuntsinger@adhezion.com
• Phone: 8287263791
• Email: jhuntsinger@adhezion.com
• Phone: 8287263791
• Email: jhuntsinger@adhezion.com
• Phone: 8287263791
• Email: jhuntsinger@adhezion.com
• Phone: 8287263791
• Email: jhuntsinger@adhezion.com
• Phone: 8287263791
• Email: jhuntsinger@adhezion.com
• Phone: 8287263791
• Email: jhuntsinger@adhezion.com
• Phone: 8287263791
• Email: jhuntsinger@adhezion.com

Device Dimensions

• Total Volume: 0.35 Milliliter
• Total Volume: 0.35 Milliliter
• Total Volume: 0.35 Milliliter
• Total Volume: 0.35 Milliliter
• Total Volume: 0.35 Milliliter
• Total Volume: 0.35 Milliliter
• Total Volume: 0.35 Milliliter
• Total Volume: 0.35 Milliliter
• Total Volume: 0.35 Milliliter
• Total Volume: 0.35 Milliliter
• Total Volume: 0.35 Milliliter
• Total Volume: 0.35 Milliliter
• Total Volume: 0.35 Milliliter
• Total Volume: 0.35 Milliliter
• Total Volume: 0.35 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M495FS035T0 [Unit of Use]
HIBCC	M495FS035T1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083354

FDA Product Code

• NZP: Sealant, Microbial

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: 2021-01-15
• Device Publish Date: 2021-01-07

Devices Manufactured by ADHEZION BIOMEDICAL, LLC

• M495FS035T0 - FloraSeal Mini: 2021-01-15FloraSeal Mini Microbial Sealant
• M495FS035T0 - FloraSeal Mini: 2021-01-15 FloraSeal Mini Microbial Sealant
• M495SP015V1 - SecurePortIV: 2019-07-22 SecurePortIV is a catheter securement adhesive to be applied as a film forming securement and sealant at the point of vascular a
• M495SP015V2 - SecurePortIV: 2019-07-22 SecurePortIV is a catheter securement adhesive to be applied as a film forming securement and sealant at the point of vascular a
• M495SP015V502 - SecurePortIV: 2019-07-22 SecurePortIV is a catheter securement adhesive to be applied as a film forming securement and sealant at the point of vascular a