ProFoam Bridge Dressing

GUDID 00851978007108

ProFoam Bridge Dressing, Case of 10 pairs (2 per package)

Pensar Medical, LLC

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

• Primary Device ID: 00851978007108
• NIH Device Record Key: 9b9abd20-746b-4d2e-adcf-383a45baac3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProFoam Bridge Dressing
• Version Model Number: 8463540 0621
• 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	00851978007108 [Unit of Use]
GS1	10851978007105 [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

• 00851978007603 - MicroDoc NPWT System: 2024-10-31 MicroDoc NPWT Dressing, 10cm x 50cm (5cm x 45cm)
• 00851978007610 - MicroDoc NPWT System: 2024-10-31 MicroDoc NPWT System, each, with 10cm x 50cm (5cm x 45cm) Dressings
• 00851978007580 - MicroDoc NPWT System: 2024-09-20 MicroDoc NPWT System, each, with 20cm x 25cm (15cm x 20cm) Breast Dressings
• 00851978007597 - MicroDoc NPWT System: 2024-09-20 MicroDoc NPWT Breast Dressing, 20cm x 25cm (15cm x 20cm)
• 00851978007559 - MicroDoc NPWT System: 2024-08-20 MicroDoc NPWT Dressing, 10cm x 20cm (5cm x 15cm)
• 00851978007566 - MicroDoc NPWT System: 2024-08-20 MicroDoc NPWT Dressing, 10cm x 30cm (5cm x 25cm)
• 00851978007573 - MicroDoc NPWT System: 2024-08-20 MicroDoc NPWT Dressing, 20cm x 25cm (15cm x 20cm)
• 00851978007542 - MicroDoc NPWT System: 2024-08-08 MicroDoc ComforTech NPWT Dressing, 15cm x 20cm