Vascette HP CP-80000

GUDID 10860003147907

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.

Koag International LLC

Surgical haemostatic agent/anti-adhesion material, animal-derived

• Primary Device ID: 10860003147907
• NIH Device Record Key: d0464a1e-e541-47db-9442-a90614b12cc7
• Commercial Distribution Discontinuation: 2030-11-25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vascette HP
• Version Model Number: CP-80000
• Catalog Number: CP-80000
• Company DUNS: 074533858
• Company Name: Koag International LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 470-755-9291
• Email: dlang@koag.life
• Phone: 470-755-9291
• Email: dlang@koag.life
• Phone: 470-755-9291
• Email: dlang@koag.life
• Phone: 470-755-9291
• Email: dlang@koag.life
• Phone: 470-755-9291
• Email: dlang@koag.life
• Phone: 470-755-9291
• Email: dlang@koag.life
• Phone: 470-755-9291
• Email: dlang@koag.life
• Phone: 470-755-9291
• Email: dlang@koag.life
• Phone: 470-755-9291
• Email: dlang@koag.life
• Phone: 470-755-9291
• Email: dlang@koag.life
• Phone: 470-755-9291
• Email: dlang@koag.life
• Phone: 470-755-9291
• Email: dlang@koag.life

Operating and Storage Conditions

• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003147900 [Primary]
GS1	10860003147907 [Package]; Contains: 00860003147900; Package: Carton [10 Units]; Discontinued: 2030-11-25; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220566

FDA Product Code

• QSY: Hemostatic Wound Dressing Without Thrombin Or Other Biologics

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[10860003147907]

Radiation Sterilization

[10860003147907]

Radiation Sterilization

[10860003147907]

Radiation Sterilization

[10860003147907]

Radiation Sterilization

[10860003147907]

Radiation Sterilization

[10860003147907]

Radiation Sterilization

[10860003147907]

Radiation Sterilization

[10860003147907]

Radiation Sterilization

[10860003147907]

Radiation Sterilization

[10860003147907]

Radiation Sterilization

[10860003147907]

Radiation Sterilization

[10860003147907]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-03
• Device Publish Date: 2025-11-25