WoundPro Control Unit

GUDID 00851978007160

WoundPro Control Unit, Control Unit Only

Pensar Medical, LLC

Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric

• Primary Device ID: 00851978007160
• NIH Device Record Key: 906aee2d-1212-4351-80ef-c523a57bd4bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WoundPro Control Unit
• Version Model Number: 8463540 0181
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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	00851978007009 [Primary]
GS1	00851978007160 [Package]; Contains: 00851978007009; Package: Box [1 Units]; In Commercial Distribution

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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• 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