FloraSeal Mini FS-035T

GUDID M495FS035T0

FloraSeal Mini Microbial Sealant

ADHEZION BIOMEDICAL, LLC

Surgical skin microbial sealant Surgical skin microbial sealant Surgical skin microbial sealant Surgical skin microbial sealant Surgical skin microbial sealant Surgical skin microbial sealant Surgical skin microbial sealant Surgical skin microbial sealant Surgical skin microbial sealant Surgical skin microbial sealant Surgical skin microbial sealant Surgical skin microbial sealant Surgical skin microbial sealant Surgical skin microbial sealant 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