Axiom® Brown

GUDID M665105233

Empyema Catheter, Round, Silicone, 3 Eyes

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: M665105233
• NIH Device Record Key: ba2eb5de-8257-47a4-bbd8-82431a5c473e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axiom® Brown
• Version Model Number: 10523
• 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	M665105230 [Primary]
HIBCC	M665105231 [Package]; Contains: M665105230; Package: Box [5 Units]; In Commercial Distribution
HIBCC	M665105233 [Package]; Contains: M665105231; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K770983

FDA Product Code

• JOL: Catheter And Tip, Suction

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-01-03
• Device Publish Date: 2016-09-23

On-Brand Devices [Axiom® Brown]

• M665105233: Empyema Catheter, Round, Silicone, 3 Eyes
• M665105223: Empyema Catheter, Round, Silicone, 2 Eyes
• M665105213: Empyema Catheter, Round, Silicone, 1 Eye
• M665105203: Empyema Catheter, Round, Silicone, No Eyes