800cc Advanced Canister w/5' Tubing

GUDID 00851978007207

800cc Advanced Canister w/5' Tubing, 16 per case

Pensar Medical, LLC

Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister

• Primary Device ID: 00851978007207
• NIH Device Record Key: 8301558a-fe8c-45d6-b892-848989067885
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 800cc Advanced Canister w/5' Tubing
• Version Model Number: 8463540 0736
• Company DUNS: 079262228
• Company Name: Pensar Medical, LLC
• Device Count: 16
• 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	00851978007207 [Unit of Use]
GS1	10851978007204 [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