Axiom®

GUDID M665111016SC3

Thoracic Catheter, Right Angle, Silicone, With Scale, Double Pouched

AXIOM MEDICAL, INCORPORATED

Pleural catheter

• Primary Device ID: M665111016SC3
• NIH Device Record Key: 8925ba26-5d77-4f28-8f8b-458a7df2b7c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axiom®
• Version Model Number: 111016SC
• 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	M665111016SC0 [Primary]
HIBCC	M665111016SC1 [Package]; Contains: M665111016SC0; Package: Box [10 Units]; In Commercial Distribution
HIBCC	M665111016SC3 [Package]; Contains: M665111016SC1; Package: Case [6 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®]

• M665516NS0: Non Sterile Continuous Tubing
• M665515NS1: Non Sterile Continuous Tubing
• M665514NS1: Non Sterile Continuous Tubing
• M665513NS1: Non Sterile Continuous Tubing
• M665512NS0: Non Sterile Continuous Tubing
• M665511NS1: Non Sterile Continuous Tubing
• M665510NS1: Non Sterile Continuous Tubing
• M665509NS1: Non Sterile Continuous Tubing
• M665508NS1: Non Sterile Continuous Tubing
• M665507NS1: Non Sterile Continuous Tubing
• M665506NS1: Non Sterile Continuous Tubing
• M665505NS1: Non Sterile Continuous Tubing
• M665504NS1: Non Sterile Continuous Tubing
• M665503NS1: Non Sterile Continuous Tubing
• M665502NS1: Non Sterile Continuous Tubing
• M665501NS1: Non Sterile Continuous Tubing
• M665111140SC3: Thoracic Catheter, Right Angle, Silicone, With Scale, Double Pouched
• M665111140S3: Thoracic Catheter, Right Angle, Silicone, With Scale
• M6651111403: Thoracic Catheter, Right Angle, Silicone
• M665111136SC3: Thoracic Catheter, Right Angle, Silicone, With Scale, Double Pouched
• M665111136S3: Thoracic Catheter, Right Angle, Silicone, With Scale
• M6651111363: Thoracic Catheter, Right Angle, Silicone
• M665111132SC3: Thoracic Catheter, Right Angle, Silicone, With Scale, Double Pouched
• M665111132S3: Thoracic Catheter, Right Angle, Silicone, With Scale
• M6651111323: Thoracic Catheter, Right Angle, Silicone
• M665111128SC3: Thoracic Catheter, Right Angle, Silicone, With Scale, Double Pouched
• M665111128S3: Thoracic Catheter, Right Angle, Silicone, With Scale
• M6651111283: Thoracic Catheter, Right Angle, Silicone
• M665111124SC3: Thoracic Catheter, Right Angle, Silicone, With Scale, Double Pouched
• M665111124S3: Thoracic Catheter, Right Angle, Silicone, With Scale
• M6651111243: Thoracic Catheter, Right Angle, Silicone
• M665111120SC3: Thoracic Catheter, Right Angle, Silicone, With Scale, Double Pouched
• M665111120S3: Thoracic Catheter, Right Angle, Silicone, With Scale
• M6651111203: Thoracic Catheter, Right Angle, Silicone
• M665111016SC3: Thoracic Catheter, Right Angle, Silicone, With Scale, Double Pouched
• M665111016S3: Thoracic Catheter, Right Angle, Silicone, With Scale
• M6651110163: Thoracic Catheter, Right Angle, Silicone
• M665100040SC3: Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched
• M665100040S3: Thoracic Catheter, Straight, Silicone, With Scale
• M6651000403: Thoracic Catheter, Straight, Silicone
• M665100036SC3: Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched
• M665100036S3: Thoracic Catheter, Straight, Silicone, With Scale
• M6651000363: Thoracic Catheter, Straight, Silicone
• M665100032XSP3: Thoracic Catheter, Straight, Silicone
• M665100032SC3: Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched
• M665100032S3: Thoracic Catheter, Straight, Silicone, With Scale
• M6651000323: Thoracic Catheter, Straight, Silicone
• M665100028XSP3: Thoracic Catheter, Straight, Silicone
• M665100028SC3: Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched
• M665100028S3: Thoracic Catheter, Straight, Silicone, With Scale