Axiom® Atraum™ With ClotStop®

GUDID M665100012AT3

Thoracic Catheter, Straight, Silicone, With ClotStop®

AXIOM MEDICAL, INCORPORATED

Pleural catheter Pleural catheter Pleural catheter Pleural catheter Pleural catheter Pleural catheter Pleural catheter Pleural catheter Pleural catheter Pleural catheter Pleural catheter Pleural catheter Pleural catheter Pleural catheter Pleural catheter

• Primary Device ID: M665100012AT3
• NIH Device Record Key: 7c3923cb-124f-4766-9748-1970e05c1bf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axiom® Atraum™ With ClotStop®
• Version Model Number: 100012AT
• Company DUNS: 094439676
• Company Name: AXIOM MEDICAL, INCORPORATED
• 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

Customer Support Contacts

• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M665100012AT0 [Primary]
HIBCC	M665100012AT1 [Package]; Contains: M665100012AT0; Package: Box [10 Units]; In Commercial Distribution
HIBCC	M665100012AT3 [Package]; Contains: M665100012AT1; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K883887

FDA Product Code

• GBS: Catheter, Ventricular, General & Plastic Surgery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-01-03
• Device Publish Date: 2018-09-23

On-Brand Devices [Axiom® Atraum™ With ClotStop®]

• M665111136ATSP1: Thoracic Catheter, Right Angle, Silicone, Double Pouched, With ClotStop®
• M665100032ATX1: Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
• M665100028ATX1: Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
• M665111140ATSC3: Thoracic Catheter, Right Angle, Silicone, With Scale, Double Pouched, With ClotStop®
• M665111140ATS3: Thoracic Catheter, Right Angle, Silicone, With Scale, With ClotStop®
• M665111140AT3: Thoracic Catheter, Right Angle, Silicone, With ClotStop®
• M665111136ATSC3: Thoracic Catheter, Right Angle, Silicone, With Scale, Double Pouched, With ClotStop®
• M665111136ATS3: Thoracic Catheter, Right Angle, Silicone, With Scale, With ClotStop®
• M665111136AT3: Thoracic Catheter, Right Angle, Silicone, With ClotStop®
• M665111132ATSC3: Thoracic Catheter, Right Angle, Silicone, With Scale, Double Pouched, With ClotStop®
• M665111132ATS3: Thoracic Catheter, Right Angle, Silicone, With Scale, With ClotStop®
• M665111132AT3: Thoracic Catheter, Right Angle, Silicone, With ClotStop®
• M665111128ATSC3: Thoracic Catheter, Right Angle, Silicone, With Scale, Double Pouched, With ClotStop®
• M665111128ATS3: Thoracic Catheter, Right Angle, Silicone, With Scale, With ClotStop®
• M665111128AT3: Thoracic Catheter, Right Angle, Silicone, With ClotStop®
• M665111124ATSC3: Thoracic Catheter, Right Angle, Silicone, With Scale, Double Pouched, With ClotStop®
• M665111124ATS3: Thoracic Catheter, Right Angle, Silicone, With Scale, With ClotStop®
• M665111124AT3: Thoracic Catheter, Right Angle, Silicone, With ClotStop®
• M665111120ATSC3: Thoracic Catheter, Right Angle, Silicone, With Scale, Double Pouched, With ClotStop®
• M665111120ATS3: Thoracic Catheter, Right Angle, Silicone, With Scale, With ClotStop®
• M665111120AT3: Thoracic Catheter, Right Angle, Silicone, With ClotStop®
• M665111016ATSC3: Thoracic Catheter, Right Angle, Silicone, With Scale, Double Pouched, With ClotStop®
• M665111016ATS3: Thoracic Catheter, Right Angle, Silicone, With Scale, With ClotStop®
• M665111016AT3: Thoracic Catheter, Right Angle, Silicone, With ClotStop®
• M665100040ATSC3: Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched, With ClotStop®
• M665100040ATS3: Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
• M665100040AT3: Thoracic Catheter, Straight, Silicone, With ClotStop®
• M665100036ATSP1: Thoracic Catheter, Straight, Silicone, Double Pouched, With ClotStop®
• M665100036ATSC3: Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched, With ClotStop®
• M665100036ATS3: Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
• M665100036AT3: Thoracic Catheter, Straight, Silicone, With ClotStop®
• M665100032ATSC3: Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched, With ClotStop®
• M665100032ATS3: Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
• M665100032AT3: Thoracic Catheter, Straight, Silicone, With ClotStop®
• M665100028ATSC3: Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched, With ClotStop®
• M665100028ATS3: Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
• M665100028AT3: Thoracic Catheter, Straight, Silicone, With ClotStop®
• M665100024ATSC3: Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched, With ClotStop®
• M665100024ATS3: Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
• M665100024AT3: Thoracic Catheter, Straight, Silicone, With ClotStop®
• M665100020ATSC3: Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched, With ClotStop®
• M665100020ATS3: Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
• M665100020AT3: Thoracic Catheter, Straight, Silicone, With ClotStop®
• M665100016ATSC3: Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched, With ClotStop®
• M665100016ATS3: Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
• M665100016AT3: Thoracic Catheter, Straight, Silicone, With ClotStop®
• M665100014ATSC3: Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched, With ClotStop®
• M665100014ATS3: Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
• M665100014AT3: Thoracic Catheter, Straight, Silicone, With ClotStop®
• M665100012ATSC3: Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched, With ClotStop®