Home GUDID 00860014518348 PurForm AM
Primary DI 00860014518348
Brand PurForm AM
Company KAIROS BIOSCIENCES LLC
Model PHM-088
Device description 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.
Published 2026-10-07
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name FRO Dressing, Wound, Drug
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FRO Dressing, Wound, Drug Unknown U
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10860014518345 Package GS1 10 In Commercial Distribution 20860014518342 Package GS1 10 In Commercial Distribution 00860014518348 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10860014518345 10860014518345 20860014518342 20860014518342 00860014518348 00860014518348 860014518348 0860014518348
GMDN Terms# Term, Definition table Term Definition Exudate-absorbent dressing, non-gel, antimicrobial A wound covering intended to absorb exudates and blood from a wound (e.g., ulcers, burns, surgical wounds, lacerations, abrasions, and/or percutaneous device wounds), and that contains an antimicrobial agent [e.g., silver (Ag), chlorhexidine gluconate (CHG)]. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate. It is intended to create a moist wound-healing environment and/or protect wounds from external contamination by microorganisms from the periwound skin. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.
Regulatory Flags# DUNS number 132083159 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06977727072259 Redermax® Antibacterial Wound Matrix Beijing Kreate Medical Co., Ltd. FRO 2026-10-08 06977727072266 Redermax® Antibacterial Wound Matrix Beijing Kreate Medical Co., Ltd. FRO 2026-10-08 06977727072273 Redermax® Antibacterial Wound Matrix Beijing Kreate Medical Co., Ltd. FRO 2026-10-08 06977727072280 Redermax® Antibacterial Wound Matrix Beijing Kreate Medical Co., Ltd. FRO 2026-10-08 06977727072457 SurCura Antibacterial Wound Matrix Beijing Kreate Medical Co., Ltd. FRO 2026-10-08 06977727072464 SurCura Antibacterial Wound Matrix Beijing Kreate Medical Co., Ltd. FRO 2026-10-08 06977727072471 SurCura Antibacterial Wound Matrix Beijing Kreate Medical Co., Ltd. FRO 2026-10-08 06977727072488 SurCura Antibacterial Wound Matrix Beijing Kreate Medical Co., Ltd. FRO 2026-10-08 10192253072723 Curity Cardinal Health 200, LLC FRO 2026-10-08 10192253072730 Curity Cardinal Health 200, LLC FRO 2026-10-08 10192253072747 Curity Cardinal Health 200, LLC FRO 2026-10-08 10192253072754 Curity Cardinal Health 200, LLC FRO 2026-10-08 10192253072761 Curity Cardinal Health 200, LLC FRO 2026-10-08 10192253072778 Curity Cardinal Health 200, LLC FRO 2026-10-08 10192253072785 Curity Cardinal Health 200, LLC FRO 2026-10-08 10192253072792 Curity Cardinal Health 200, LLC FRO 2026-10-08 10192253072808 Curity Cardinal Health 200, LLC FRO 2026-10-08 10192253072815 Curity Cardinal Health 200, LLC FRO 2026-10-08 10192253072822 Curity Cardinal Health 200, LLC FRO 2026-10-08 00860014518331 PurForm AM KAIROS BIOSCIENCES LLC FRO 2026-10-07 00886333217595 V+Pad ARGON MEDICAL DEVICES, INC. FRO 2026-10-07 00612553000163 VERIS HARTMANN USA, INC. FRO 2026-10-01 00612553000170 VERIS HARTMANN USA, INC. FRO 2026-10-01 00612553000187 VERIS HARTMANN USA, INC. FRO 2026-10-01 00612553000194 VERIS HARTMANN USA, INC. FRO 2026-10-01 00194346726707 equate WAL-MART STORES, INC. FRO 2026-09-30 00194346726714 equate WAL-MART STORES, INC. FRO 2026-09-30 10885380214714 Curity Cardinal Health 200, LLC FRO 2026-09-30 10885380214738 Curity Cardinal Health 200, LLC FRO 2026-09-30 00810226440944 ViveCare VIVE HEALTH LLC FRO 2026-09-29