Aspiration Tube Set PA110100US

GUDID 05391539370074

The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connector connects to the hub of a Millipede 070 Aspiration Catheter. The suction connector connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter.

PERFUZE LIMITED

Disposable vacuum tubing

• Primary Device ID: 05391539370074
• NIH Device Record Key: 92275f5c-5956-4939-bb53-64e1105cb8b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aspiration Tube Set
• Version Model Number: 1.0
• Catalog Number: PA110100US
• Company DUNS: 985715471
• Company Name: PERFUZE LIMITED
• 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: false
• 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	05391539370074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232524

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: 2023-11-10
• Device Publish Date: 2023-11-02

Devices Manufactured by PERFUZE LIMITED

• 05391539370050 - Zipline 070 Access Catheter: 2024-12-09 The Zipline 070 Access Catheter is a single-use device designed to deliver large-bore catheters to the neurovasculature using st
• 05391539370067 - Zipline 088 Access Catheter: 2024-12-09 The Zipline 088 Access Catheter is a single-use device designed to deliver large-bore catheters to the neurovasculature using st
• 05391539370142 - Millipede 088 Access Catheter: 2023-12-26 The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The cat
• 05391539370005 - Millipede 088 Access Catheter: 2023-11-10 The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The cat
• 05391539370074 - Aspiration Tube Set: 2023-11-10The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connector connects to the hub of a Millipede 070 Aspiration Catheter. The suction connector connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter.
• 05391539370074 - Aspiration Tube Set: 2023-11-10 The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rot
• 05391539370098 - Millipede 070 Aspiration Catheter: 2023-11-10 The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valv
• 05391539370111 - Millipede 088 Access Catheter: 2023-11-10 The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The cat