Axiom® Atraum™ With ClotStop®

GUDID M665100016AT3

Thoracic Catheter, Straight, Silicone, With ClotStop®

AXIOM MEDICAL, INCORPORATED

Pleural catheter

• Primary Device ID: M665100016AT3
• NIH Device Record Key: cf9b026d-932d-4c69-8116-c60ec19e48b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axiom® Atraum™ With ClotStop®
• Version Model Number: 100016AT
• 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	M665100016AT0 [Primary]
HIBCC	M665100016AT1 [Package]; Contains: M665100016AT0; Package: Box [10 Units]; In Commercial Distribution
HIBCC	M665100016AT3 [Package]; Contains: M665100016AT1; 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®