Basic Series Combo Pack, Large

GUDID 00851978007337

Basic Series Large Combo Pack (12 ea 0585 kits; 4 ea 0222 canisters)

Pensar Medical, LLC

Negative-pressure wound therapy system dressing set

• Primary Device ID: 00851978007337
• NIH Device Record Key: bbe6c6f2-9a00-4711-8aaa-592cc202e5bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Basic Series Combo Pack, Large
• Version Model Number: 8463540 0585-CB
• 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: 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	00851978007337 [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

• 00851978007689 - MicroDoc NPWT System: 2025-03-27 MicroDoc NPWT System, each, with 20cm x 25cm (15cm x 20cm) ComforTech+ Dressings
• 00851978007696 - MicroDoc NPWT System: 2025-03-27 MicroDoc NPWT System, Each, with 15cm x 20cm (10cm x 15cm) ComforTech+ Dressings
• 00851978007702 - MicroDoc NPWT System: 2025-03-27 MicroDoc NPWT System, each, with 10cm x 20cm (5cm x 15cm) ComforTech+ Dressings
• 00851978007719 - MicroDoc NPWT System: 2025-03-27 MicroDoc NPWT System, each, with 10cm x 50cm (5cm x 45cm) ComforTech+ Dressings
• 00851978007726 - MicroDoc NPWT System: 2025-03-27 MicroDoc NPWT System, each, with 10cm x 30cm (5cm x 25cm) ComforTech+ Dressings
• 00851978007733 - MicroDoc NPWT System: 2025-03-27 MicroDoc NPWT System, each, with 10cm x 40cm (5cm x 35cm) ComforTech+ Dressings
• 00851978007740 - MicroDoc NPWT System: 2025-03-27 MicroDoc ComforTech+ NPWT Dressing, 15cm x 20cm (10cm x 15cm)
• 00851978007757 - MicroDoc NPWT System: 2025-03-27 MicroDoc NPWT ComforTech+ Dressing, 20cm x 25cm (15cm x 20cm)