PurForm AM

GUDID 10860014518321

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.

KAIROS BIOSCIENCES LLC

Exudate-absorbent dressing, non-gel, antimicrobial

• Primary Device ID: 10860014518321
• NIH Device Record Key: 6f74e906-deb7-4333-a7c8-49b1bd50c502
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PurForm AM
• Version Model Number: PHM-125
• Company DUNS: 132083159
• Company Name: KAIROS BIOSCIENCES LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 3852226255
• Email: contact@kairosbiosciences.com
• Phone: 3852226255
• Email: contact@kairosbiosciences.com
• Phone: 3852226255
• Email: contact@kairosbiosciences.com
• Phone: 3852226255
• Email: contact@kairosbiosciences.com
• Phone: 3852226255
• Email: contact@kairosbiosciences.com
• Phone: 3852226255
• Email: contact@kairosbiosciences.com
• Phone: 3852226255
• Email: contact@kairosbiosciences.com
• Phone: 3852226255
• Email: contact@kairosbiosciences.com
• Phone: 3852226255
• Email: contact@kairosbiosciences.com
• Phone: 3852226255
• Email: contact@kairosbiosciences.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860014518324 [Primary]
GS1	10860014518321 [Package]; Contains: 00860014518324; Package: Inner Pack [10 Units]; In Commercial Distribution
GS1	20860014518328 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223310

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-11-28
• Device Publish Date: 2025-11-20

On-Brand Devices [PurForm AM]

• 10860014518321: Antimicrobial silicone foam wound dressing containing PHMB, intended for the management of acute
• 00860014518317: Antimicrobial silicone foam wound dressing containing PHMB, intended for the management of acute