072 Aspiration System

GUDID 00857545008103

072 Aspiration Tubing

Q'APEL MEDICAL LLC

Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter

• Primary Device ID: 00857545008103
• NIH Device Record Key: 4a3d151f-39be-4d62-ab61-2658acbe7cfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 072 Aspiration System
• Version Model Number: FG 00995
• Company DUNS: 020937374
• Company Name: Q'APEL 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857545008103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222786

FDA Product Code

• NRY: Catheter, Thrombus Retriever

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: 2023-10-19
• Device Publish Date: 2023-10-11