Silver ProFoam Hydrophobic Dressing, Medium

GUDID 00851978007122

Silver ProFoam Hydrophobic Dressing, Medium, 10 per case

Pensar Medical, LLC

Negative-pressure wound therapy system foam dressing, antimicrobial Negative-pressure wound therapy system foam dressing, antimicrobial Negative-pressure wound therapy system foam dressing, antimicrobial Negative-pressure wound therapy system foam dressing, antimicrobial Negative-pressure wound therapy system foam dressing, antimicrobial Negative-pressure wound therapy system foam dressing, antimicrobial Negative-pressure wound therapy system foam dressing, antimicrobial Negative-pressure wound therapy system foam dressing, antimicrobial Negative-pressure wound therapy system foam dressing, antimicrobial Negative-pressure wound therapy system foam dressing, antimicrobial Negative-pressure wound therapy system foam dressing, antimicrobial Negative-pressure wound therapy system foam dressing, antimicrobial Negative-pressure wound therapy system foam dressing, antimicrobial Negative-pressure wound therapy system foam dressing, antimicrobial Negative-pressure wound therapy system foam dressing, antimicrobial

• Primary Device ID: 00851978007122
• NIH Device Record Key: 42136572-6693-4510-9a95-1874f064612b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silver ProFoam Hydrophobic Dressing, Medium
• Version Model Number: 8463540 0599
• Company DUNS: 079262228
• Company Name: Pensar Medical, LLC
• Device Count: 10
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851978007122 [Unit of Use]
GS1	10851978007129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150960

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

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: 2022-10-17
• Device Publish Date: 2022-10-07

Devices Manufactured by Pensar Medical, LLC

• 00851978007153 - MicroDoc NPWT Control Unit: 2022-10-20 MicroDoc NPWT Systems, 5 per box
• 00851978007429 - Advanced Series Y-Connector: 2022-10-19 Advanced Series Y-Connector, 10 per case
• 00851978007245 - Basic Series Hydrophobic Dressing Kit, Large: 2022-10-18 Basic Series Hydrophobic Dressing Kit, Large, Case of 10
• 00851978007269 - Advanced Series Hydrophobic Dressing Kit, Medium: 2022-10-18 Advanced Series Hydrophobic Dressing Kit, Medium, 10 per case
• 00851978007276 - Advanced Series Hydrophobic Dressing Kit, Large: 2022-10-18 Advanced Series Hydrophobic Dressing Kit, Large, 10 per case
• 00851978007382 - Basic Series StingRay Suction Bell: 2022-10-18 Basic Series StingRay Suction Bell, 10 per case
• 00851978007399 - Advanced Series StingRay Suction Bell: 2022-10-18 Advanced Series StingRay Suction Bell, 10 per box
• 00851978007405 - Mini StingRay: 2022-10-18 Mini StingRay, 10 per box