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 IDM495SP015V1
NIH Device Record Keybe015aba-5e81-4ba2-bb85-1d08a8d32a16
Commercial Distribution StatusIn Commercial Distribution
Brand NameSecurePortIV
Version Model NumberSP-015V
Catalog NumberSP-015V
Company DUNS827716437
Company NameADHEZION BIOMEDICAL, LLC
Device Count15
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone828-726-3791
Emailmwyer@adhezion.com

Device Dimensions

Total Volume0.15 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM495SP015V0 [Unit of Use]
HIBCCM495SP015V1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NZPSealant, Microbial

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-07-22
Device Publish Date2018-01-30

On-Brand Devices [SecurePortIV]

M495SP015V502SecurePortIV is a catheter securement adhesive to be applied as a film forming securement and se
M495SP015V2SecurePortIV is a catheter securement adhesive to be applied as a film forming securement and se
M495SP015V1SecurePortIV is a catheter securement adhesive to be applied as a film forming securement and se

Trademark Results [SecurePortIV]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SECUREPORTIV
SECUREPORTIV
87634950 not registered Live/Pending
Adhezion Biomedical LLC
2017-10-05
SECUREPORTIV
SECUREPORTIV
86018858 not registered Dead/Abandoned
Adhezion Biomedical LLC
2013-07-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.