SecurePortIV

Basic Information

• Brand Name: SecurePortIV
• Primary DI: M495SP015V1
• Version / Model: SP-015V
• Catalog Number: SP-015V
• Company Name: ADHEZION BIOMEDICAL, LLC
• Labeler DUNS: 827716437
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 15
• Record Status: Published
• Publish Date: 2018-01-30
• Public Version: 7
• Public Version Date: 2025-11-20
• Public Version Status: Update
• Public Device Record Key: be015aba-5e81-4ba2-bb85-1d08a8d32a16

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NZP	Sealant, Microbial	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56631	Wearable percutaneous catheter/tube holder, single-use	A device designed to fix a percutaneous catheter, tube, and/or drain (e.g., IV, epidural, or drainage catheter, GI tube) to a patient's body without suturing; it may additionally be intended for holding a non-surgically-invasive tube (e.g., nasogastric tube) to the patient (universal holder). It is designed as an adhesive pad, strip, or bandage that will attach to the patient's skin, sometimes with the exposed side having an integrated fixation mechanism (e.g., Velcro hook/loop closure) or a mechanical closure, to hold the catheter/tube in place. It may include a transparent film portion intended for fixation site monitoring. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M495SP015V1	HIBCC
Unit of Use	M495SP015V0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K170505	000

Device Sizes

Type	Value	Unit	Text
Total Volume	.15	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Recommended storage: away from moisture, direct heat, or direct light
• Type: Storage Environment Temperature
• Temperature Range: – 86 Degrees Fahrenheit