SecurePortIV SP-015V

GUDID M495SP015V1

SecurePortIV is a catheter securement adhesive to be applied as a film forming securement and sealant at the point of vascular access catheter skin entry.

ADHEZION BIOMEDICAL, LLC

Wearable percutaneous catheter/tube holder

• Primary Device ID: M495SP015V1
• NIH Device Record Key: be015aba-5e81-4ba2-bb85-1d08a8d32a16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SecurePortIV
• Version Model Number: SP-015V
• Catalog Number: SP-015V
• Company DUNS: 827716437
• Company Name: ADHEZION BIOMEDICAL, LLC
• Device Count: 15
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 828-726-3791
• Email: mwyer@adhezion.com

Device Dimensions

• Total Volume: 0.15 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M495SP015V0 [Unit of Use]
HIBCC	M495SP015V1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170505

FDA Product Code

• NZP: Sealant, Microbial

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-07-22
• Device Publish Date: 2018-01-30

On-Brand Devices [SecurePortIV]

• M495SP015V502: SecurePortIV is a catheter securement adhesive to be applied as a film forming securement and se
• M495SP015V2: SecurePortIV is a catheter securement adhesive to be applied as a film forming securement and se
• M495SP015V1: SecurePortIV is a catheter securement adhesive to be applied as a film forming securement and se