ActiGraft

Basic Information

• Brand Name: ActiGraft
• Primary DI: 10860000244319
• Version / Model: RD2201
• Company Name: REDDRESS LTD
• Labeler DUNS: 533179532
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2025-03-23
• Public Version: 1
• Public Version Date: 2025-03-31
• Public Version Status: New
• Public Device Record Key: 9572742e-968f-430a-9dcb-4f02f9cb1073

Device Description

The ActiGraft is intended to be used at point-of-care for the safe and rapid preparation of Whole Blood Clot (WBC) from a small sample of a patient’s own peripheral blood.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PMQ	Peripheral Blood Processing Device For Wound Management	Hematology	864.9245	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64707	Wound therapy autologous blood clot preparation kit	A collection of devices intended to be used at the point-of-care to draw blood from a patient and produce an autologous whole blood clot tissue mass (gel-like) for temporary topical application to an exuding skin wound (e.g., diabetic or pressure ulcer, surgical wound) to promote healing. The kit includes devices for venous blood harvesting (e.g., needles, tourniquet, gauze), in vitro blood clot preparation (e.g., coagulation tissue mould, coagulation-inducing reagent, syringe/needles), and clot application to the wound (e.g., dressings). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00860000244312	GS1
Primary	10860000244319	GS1