WoundPro UniFlow Connector

GUDID 00851978007085

WoundPro UniFlow Y Connector Case of 10

Pensar Medical, LLC

Low-pressure tubing connector, single-use, non-sterile

• Primary Device ID: 00851978007085
• NIH Device Record Key: 666f0885-e362-4d39-8267-44d2425da52e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WoundPro UniFlow Connector
• Version Model Number: 8463540 0674
• 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: false
• 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	00851978007085 [Unit of Use]
GS1	10851978007082 [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: false

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

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• 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