ActiGraft

GUDID 00860000244312

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.

REDDRESS LTD

Wound therapy autologous blood clot preparation kit

• Primary Device ID: 00860000244312
• NIH Device Record Key: 9572742e-968f-430a-9dcb-4f02f9cb1073
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ActiGraft
• Version Model Number: RD2201
• Company DUNS: 533179532
• Company Name: REDDRESS LTD
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000244312 [Unit of Use]
GS1	10860000244319 [Primary]

FDA Product Code

• PMQ: Peripheral Blood Processing Device For Wound Management

Sterilization

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

[00860000244312]

Ethylene Oxide

[00860000244312]

Ethylene Oxide

[00860000244312]

Ethylene Oxide

[00860000244312]

Ethylene Oxide

[00860000244312]

Ethylene Oxide

[00860000244312]

Ethylene Oxide

[00860000244312]

Ethylene Oxide

[00860000244312]

Ethylene Oxide

[00860000244312]

Ethylene Oxide

[00860000244312]

Ethylene Oxide

[00860000244312]

Ethylene Oxide

[00860000244312]

Ethylene Oxide

[00860000244312]

Ethylene Oxide

[00860000244312]

Ethylene Oxide

[00860000244312]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-31
• Device Publish Date: 2025-03-23