Vascette HP

Basic Information

• Brand Name: Vascette HP
• Primary DI: 00860003147900
• Version / Model: CP-80000
• Catalog Number: CP-80000
• Company Name: Koag International LLC
• Labeler DUNS: 074533858
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-25
• Public Version: 1
• Public Version Date: 2025-12-03
• Public Version Status: New
• Public Device Record Key: d0464a1e-e541-47db-9442-a90614b12cc7
• Distribution End Date: 2030-11-25

Device Description

Vascette HP is a single-use, hemostatic dressing incorporating a plant-based, polysaccharide, hemostatic foam agent. Vascette HP is intended for use as a temporary topical dressing for the management of bleeding from vascular access sites and percutaneous catheters.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
65102	Surgical haemostatic agent/anti-adhesion material, animal-derived	A bioabsorbable implantable membrane comprised of polysaccharides [at least one animal-derived (e.g., chitin)] intended to be topically applied to superficial surgical wounds or optionally implanted around internal surgical wounds to facilitate local haemostasis, and to function internally as a barrier to reduce the incidence of adhesions between adjacent anatomical structures. It is in the form of a paper-like membrane applied directly to the wound where it takes the form of a gel upon wound adherence and eventually biodegrades; neither antimicrobials nor pharmaceuticals are included. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10860003147907	GS1	Carton	10	In Commercial Distribution	2030-11-25
Primary	00860003147900	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K220566	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -25 – 60 Degrees Celsius