Search Results
Found 4 results
510(k) Data Aggregation
K Number
K223669Device Name
SecurePortIV Advanced Catheter Securement Adhesive
Manufacturer
Adhezion Biomedical, LLC.
Date Cleared
2023-06-12
(187 days)
Product Code
NZP
Regulation Number
878.4370Why did this record match?
Product Code :
NZP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SECUREPORTIV® ADVANCED Catheter Securement Adhesive is to be applied as a film forming securement and sealant at the point of vascular access catheter skin entry. The film holds the catheter to the skin to reduce catheter movement, migration, and/or dislodgment. It is used to protect the catheter skin entry site by creating a sealant that immobilizes surface bacteria, preventing them from entering into the catheter skin entry site while a moisture barrier. SECUREPORTIV® ADVANCED is intended to be used with a transparent film dressing for the securement of short-term and long-term vascular access catheters including peripheral IVs, PICCs, and CVCs.
Device Description
SecurePortIV Advanced Catheter Adhesive is a sterile, professional liquid cyanoacrylatebased adhesive containing a monomeric formulation (2-octyl cyanoacrylate) and the colorant D&C Violet #2. The device is an applicator with the formulation incorporated in an ampoule housed in a tapered plastic tube. The SecurePortIV Advanced liquid is applied as a film forming securement and sealant at the point of catheter skin entry, polymerizing in minutes.
Ask a Question
K Number
K170505Device Name
SecurePortIV Catheter Securement Adhesive
Manufacturer
Adhezion Biomedical, LLC
Date Cleared
2017-09-29
(220 days)
Product Code
NZP
Regulation Number
878.4370Why did this record match?
Product Code :
NZP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SecurePortIV™ catheter securement adhesive is to be applied as a film forming securement and sealant at the point of vascular access catheter skin entry. The film holds the catheter to the skin to reduce catheter movement, migration, and/or dislodgment. It is used to protect the catheter skin entry site by creating a sealant that immobilizes surface bacteria, preventing them from entering into the catheter skin entry site while also providing a moisture barrier. SecurePortV™ is intended to be used with a transparent film dressing on short-term and long-term vascular access catheters including peripheral IVs, PICCs, and CVCs.
Device Description
SecurePortIV Catheter Adhesive is a sterile, professional liquid cyanoacrylate-based adhesive containing a two monomeric formulation (2-octyl cyanoacrylate and butyl cyanoacrylate) and the colorant D&C Violet #2. The device is an applicator with the formulation incorporated in an ampoule housed in a tapered plastic tube.
The SecurePortIV liquid is applied as a film forming securement and sealant at the point of catheter skin entry, polymerizing in minutes. It is intended to be used in conjunction with a transparent film dressing.
Ask a Question
K Number
K083354Device Name
FLORASEAL, MODEL FS350D
Manufacturer
ADHEZION BIOMEDICAL
Date Cleared
2009-07-20
(249 days)
Product Code
NZP
Regulation Number
878.4370Why did this record match?
Product Code :
NZP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Flora Seal™ Microbial Sealant is intended for use after topical operative skin preparations, with standard surgical draping, and prior to a surgical incision. The product is used to reduce the risk of the skin flora contamination throughout a surgical procedure.
Device Description
Flora Seal Microbial Sealant is a film forming, cyanoacrylate based microbial sealant provided in a ready to use applicator. Each applicator consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. This applicator tray with sponge tip is contained in an outer Tyvek pouch.
Ask a Question
K Number
K052870Device Name
INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200
Manufacturer
KIMBERLY-CLARK CORP.
Date Cleared
2006-09-29
(353 days)
Product Code
NZP
Regulation Number
878.4370Why did this record match?
Product Code :
NZP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Integuseal Microbial Sealant is intended for use after typical preoperative skin preparations, with standard surgical draping, and prior to a surgical incision. The product is used to reduce the risk of skin flora contamination throughout a surgical procedure.
Device Description
INTEGUSEAL Microbial Sealant is a film-forming cyanoacrylate-based product provided in a ready-to-use applicator. The Sealant is intended to be applied on the skin over commonly used surgical skin preparation products with standard surgical draping prior to a surgical incision. Upon polymerization, INTEGUSEAL bonds to the skin, immobilizing the bacteria and thereby reducing the risk of skin flora contamination throughout a surgical procedure.
Ask a Question
Page 1 of 1