ActivHeal 9025148

GUDID 15032749025145

Silicone PHMB Foam Border Dressing 8x8cm

ADVANCED MEDICAL SOLUTIONS LIMITED

Exudate-absorbent dressing, non-gel, antimicrobial

• Primary Device ID: 15032749025145
• NIH Device Record Key: 5b808c95-45d1-4f1d-99fe-cb44cf2dc99f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ActivHeal
• Version Model Number: PHMB Silicone Adhesive Foam Border
• Catalog Number: 9025148
• Company DUNS: 770434090
• Company Name: ADVANCED MEDICAL SOLUTIONS LIMITED
• 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: 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	15032749025145 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190819

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: 2023-05-11
• Device Publish Date: 2023-05-03

On-Brand Devices [ActivHeal]

• 15032749035281: Silver Alginate NON ADHERENT DRESSING 5X5CM
• 15032749001767: Hydrogel Tube 15g
• 15032749000074: Hydrogel Tube 8g
• 05032749024981: Moisture Wicking Fabric with Silver Dressing.
• 05032749024967: Moisture Wicking Fabric with Silver Dressing.
• 15032749001583: SILICONE FOAM NON BORDER ADHESIVE 20X20CM
• 15032749001576: SILICONE FOAM NON BORDER ADHESIVE 10X20CM
• 15032749001569: SILICONE FOAM NON BORDER ADHESIVE 10X10CM
• 15032749001552: SILICONE FOAM NON BORDER ADHESIVE 7.5X7.5CM
• 15032749001545: SILICONE FOAM NON BORDER ADHESIVE 5X5CM
• 15032749001538: SILICONE FOAM BORDER Sacral
• 15032749001521: SILICONE FOAM BORDER 20x20CM
• 15032749001514: SILICONE FOAM BORDER 15x15CM
• 15032749001507: SILICONE FOAM BORDER 10x20CM
• 15032749001491: SILICONE FOAM BORDER 12.5x12.5CM
• 15032749001484: SILICONE FOAM BORDER 10x10CM
• 15032749001477: SILICONE FOAM BORDER 7.5X7.5CM
• 15032749001446: SILICONE FOAM NON BORDER ADHESIVE 15X15CM
• 15032749001279: SILICONE WOUND CONTACT LAYER 15x15CM
• 15032749001262: SILICONE WOUND CONTACT LAYER 10x20CM
• 15032749001255: SILICONE WOUND CONTACT LAYER 10x10CM
• 15032749001248: SILICONE WOUND CONTACT LAYER 5X7.5CM
• 15032749000326: NON ADHESIVE FOAM TRILAM TRACHEOSTOMY 10X10CM
• 15032749000319: NON ADHESIVE FOAM TRILAM 20X20CM
• 15032749000296: NON ADHESIVE FOAM TRILAM 10X10CM
• 15032749000289: NON ADHESIVE FOAM TRILAM 7.5X7.5CM
• 15032749000272: NON ADHESIVE FOAM TRILAM 5X5CM
• 15032749000265: Bilaminate Foam Adhesive Dressing 20x20cm
• 15032749000258: Bilaminate Foam Adhesive Dressing 15x15cm
• 15032749000241: Bilaminate Foam Adhesive Dressing 12.5x12.5cm
• 15032749000234: Bilaminate Foam Adhesive Dressing 10x10cm
• 15032749000203: NON ADHESIVE FOAM TRILAM 10X20CM
• 15032749000135: Bilaminate Foam Adhesive Dressing 7.5x7.5cm
• 15032749000050: NON ADHESIVE FOAM TRILAM HEEL
• 15032749022717: PHMB Foam Adhesive 10x20cm
• 15032749021390: PHMB Foam Adhesive Sacral
• 15032749001323: PHMB Foam Adhesive 20x20cm
• 15032749001316: PHMB Foam Adhesive 15x15cm
• 15032749001293: PHMB Foam Adhesive 10x10cm
• 15032749001286: PHMB Foam Adhesive 7.5cmx7.5cm
• 15032749025480: AQUAFIBER EXTRA HPD 41-2AP 10x12cm
• 15032749025473: AQUAFIBER Ag SILVER Alginate 10x12cm
• 15032749025206: Silicone PHMB Foam Border Dressing Sacral
• 15032749025190: Silicone PHMB Foam Border Dressing 20x20cm
• 15032749025183: Silicone PHMB Foam Border Dressing 15x15cm
• 15032749025176: Silicone PHMB Foam Border Dressing 10x20cm
• 15032749025169: Silicone PHMB Foam Border Dressing 12.5x12.5cm
• 15032749025152: Silicone PHMB Foam Border Dressing 10x10cm
• 15032749025145: Silicone PHMB Foam Border Dressing 8x8cm
• 15032749023677: AQUAFIBER EXTRA HPD 41-2AP 2x46cm