AccessGUDID - DEVICE: ActiGraft (10860000244319)

GUDID

Device Identifier (DI) Information

Brand Name: ActiGraft
Version or Model: RD2201
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: REDDRESS LTD

Primary DI Number: 10860000244319
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 533179532 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PMQ	Peripheral Blood Processing Device For Wound Management

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9572742e-968f-430a-9dcb-4f02f9cb1073
Public Version Date: March 31, 2025
Public Version Number: 1
DI Record Publish Date: March 23, 2025