MicroDoc NPWT System

GUDID 00851978007580

MicroDoc NPWT System, each, with 20cm x 25cm (15cm x 20cm) Breast Dressings

Pensar Medical, LLC

Negative-pressure wound therapy system, electric, single-use

• Primary Device ID: 00851978007580
• NIH Device Record Key: 7e377a72-b0be-4abc-8a63-5afc026a9478
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MicroDoc NPWT System
• Version Model Number: 8463550 4005
• Company DUNS: 079262228
• Company Name: Pensar Medical, 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: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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	00851978007580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200223

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-20
• Device Publish Date: 2024-09-12

On-Brand Devices [MicroDoc NPWT System]

• 00851978007511: MicroDoc NPWT System, each, with Dressing Strips
• 00851978007504: MicroDoc NPWT System, Each, with 6" x 6" Dressings
• 00851978007535: MicroDoc NPWT System, each, with 20cm x 25cm Dressings
• 00851978007528: MicroDoc NPWT System, each, with 10cm x 30cm Dressings
• 00851978007542: MicroDoc ComforTech NPWT Dressing, 15cm x 20cm
• 00851978007573: MicroDoc NPWT Dressing, 20cm x 25cm (15cm x 20cm)
• 00851978007566: MicroDoc NPWT Dressing, 10cm x 30cm (5cm x 25cm)
• 00851978007559: MicroDoc NPWT Dressing, 10cm x 20cm (5cm x 15cm)
• 00851978007597: MicroDoc NPWT Breast Dressing, 20cm x 25cm (15cm x 20cm)
• 00851978007580: MicroDoc NPWT System, each, with 20cm x 25cm (15cm x 20cm) Breast Dressings
• 00851978007610: MicroDoc NPWT System, each, with 10cm x 50cm (5cm x 45cm) Dressings
• 00851978007603: MicroDoc NPWT Dressing, 10cm x 50cm (5cm x 45cm)