SecurePortIV

Primary DI
M495SP015V502
Brand
SecurePortIV
Company
ADHEZION BIOMEDICAL, LLC
Model
SP-015V50
Catalog number
SP-015V50
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.SP-015V50 unit box contains 50 SP-015V applicators
Published
2018-04-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NZPSealant, Microbial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NZPSealant, MicrobialGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170505000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170505000SecurePortIV Catheter Securement AdhesiveAdhezion Biomedical, LLC2017-09-29NZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M495SP015V502PrimaryHIBCC0
M495SP015V0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wearable percutaneous catheter/tube holderA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0.15Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Recommended storage: away from moisture, direct heat, or direct light
Storage Environment Temperature0 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
828-726-3791mwyer@adhezion.com

Regulatory Flags#

DUNS number
827716437
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M495SP015V1SecurePortIVSP-015VSP-015V2018-01-30
M495SP015V2SecurePortIVSP-015VSP-015V2018-02-05
M495FS035T1FloraSeal MiniFS035TFS-035T2021-01-07
M495FS035T0FloraSeal MiniFS035TFS-035T2021-01-07
M495FS250D1FloraSealFS250DFS-250D2016-11-21
M495SS035T1SurgiSealSS-035TSS-035T2016-05-18
M495SS050S1SurgiSealSS-050SSS-050S2016-05-18
M495ST050S1SurgiSealST-050SST-050S2016-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05036912001595INTEGUSEALADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDNZP2024-11-26
05036912001625INTEGUSEALADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDNZP2024-11-26
M495FS035T1FloraSeal MiniADHEZION BIOMEDICAL, LLCNZP2021-01-07
M495FS035T0FloraSeal MiniADHEZION BIOMEDICAL, LLCNZP2021-01-07
00193494337360AVANOSAvanos Medical, Inc.NZP2020-07-16
00193494337377AVANOSAvanos Medical, Inc.NZP2020-07-16
20193494337364AVANOSAvanos Medical, Inc.NZP2020-07-16
10193494337374AVANOSAvanos Medical, Inc.NZP2020-07-16
M495SP015V2SecurePortIVADHEZION BIOMEDICAL, LLCNZP2018-02-05
M495SP015V1SecurePortIVADHEZION BIOMEDICAL, LLCNZP2018-01-30
10680651337365HalyardAvanos Medical, Inc.NZP2017-03-15
10680651337372HalyardAvanos Medical, Inc.NZP2017-03-15
M495FS250D1FloraSealADHEZION BIOMEDICAL, LLCNZP2016-11-21