GUDIDData
gudid Primary ID: PHM-125

PurForm AM (UDI PHM-125)

Manufactured by KAIROS BIOSCIENCES LLC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for PurForm AM - Primary ID PHM-125

Device Regulatory Overview

The PurForm AM (Model/Catalog Number: PHM-125) is a medical device manufactured by KAIROS BIOSCIENCES LLC. This product is indexed under FDA Product Code / Category Classification FRO within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
PHM-125
Product Code / EMDN
FRO
Device Name
Antimicrobial silicone foam wound dressing containing PHMB, intended for the management of acute and chronic wounds including post-surgical incisions, partial- and full-thickness wounds, pressure ulcers, diabetic ulcers, and venous leg ulcers.
Database Sync Date
2026-08-09 09:49:15

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of PurForm AM?

The registered manufacturer of record for PurForm AM is KAIROS BIOSCIENCES LLC.

What is the Primary UDI-DI identifier for PurForm AM?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is PHM-125.

What classification code is assigned to this device?

This device is registered under product classification code FRO.

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